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Full Time
1/20/2025
Waltham, MA 02254
(11.5 miles)
General SummaryThe Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. This role includes verifying instrument placement, checking for good working order, and preparing trays for processing. The QA specialist provides immediate feedback and coaching, documents data in provided software, and identifies discrepancies/errors in count sheets.Additionally, the QA specialist may assist in developing, recommending, and implementing educational needs, internal standards, policies, and procedures to improve the quality and effectiveness of patient care and sterile processing. Participation in hospital, departmental, and multidisciplinary programs, committees, and special projects may also be required.Values StatementThe Sterile Processing Quality Assurance Specialist embodies the hospital’s core values in all interactions with patients, families, and colleagues.Duties NoticeThe following statements describe the essential duties of the person assigned to this job. They are not intended as an exhaustive list of all job duties and responsibilities. In the event of a public health emergency, you may be asked to assume additional duties in other areas of the organization if needed.Principal Duties and ResponsibilitiesKit Review and Accuracy: Maintains review kits for accuracy and instrument functionality. Ensures every kit is audited and entered into the database.Error Trend Identification: Identifies trends in kit errors and reports findings from SPM collation to monthly staff meetings.Immediate Feedback and Coaching: Provides immediate feedback to assemblers, offers coaching to staff when gaps arise, and recognizes staff that are unreceptive to coaching. Recommends focused needs to educators and specialty training.Staff Evaluation: Recognizes staff that are unreceptive to feedback and reports findings and trends.Case Cart Review: Reviews and inspects case carts for accuracy and completeness. Helps create a missing/priority list to complete case carts.Discrepancy Reporting: Accurately reports all discrepancies.Quality Assurance Support: Supports enterprise programs for quality assurance needs.Other Duties: Performs other duties as assigned.Certification/RegistrationCertification/Registration Required: SPD Certification, Level II TechCertification/Registration Preferred: CISEducationRequired Education: High School Diploma or Surgical TechnologistPreferred Education: Bachelor’s DegreeWork ExperienceRequired Work Experience: Certification in SPD, 5+ years of experiencePreferred Work Experience: None specifiedKnowledge, Skills, and AbilitiesAnalytical Skills: Ability to resolve complex problems requiring the application of clinical, scientific, or technical principles, theories, and concepts and in-depth, cross-functional, experienced-based knowledge.Communication Skills: Effectively deal with conflicting views or issues, mediate fair solutions, and possess well-developed writing skills.Interpersonal Skills: Ability to communicate effectively with supervisors, coworkers, and all levels of hospital staff, including the Operating Room and physicians.Multi-tasking: Capable of planning, organizing, and multi-tasking projects. Flexible and self-motivated.Technical Reading: Ability to read and understand applicable IFU and SPM count sheets.Customer Centric Behavior: Demonstrated customer-centric behavior.OR Workflow Knowledge: Familiarity with OR workflow, procedures, medical terminology, and instrumentation.Infection Control: Knowledge of infection control and health & safety policies and procedures.Cultural Sensitivity: Sensitivity to recognize, appreciate, and incorporate differences, diversity, and preferences into the provision of care.Software Proficiency: Thorough working knowledge of Microsoft Office applications and the capability to learn software programs.
Full Time
1/17/2025
Bellingham, MA 02019
(33.5 miles)
Join Our Team at KARL STORZ U.S. – Elevate Quality and Drive Continuous ImprovementAre you passionate about quality and regulatory compliance in the medical device industry Do you thrive in a leadership role, guiding teams to achieve excellence If so, we want you to join our team as a Quality Assurance Manager at KARL STORZ, a global leader in endoscopy, medical device technology, and healthcare solutions.Why KARL STORZ Be Part of Innovation: Drive continuous improvement and contribute to products that impact healthcare worldwide.Leadership Impact: Lead and develop a talented team, influencing quality initiatives and shaping the future of medical technology.Career Growth: With our commitment to ongoing learning, you’ll have ample opportunities to advance and expand your skill set in a dynamic environment.What you will be doing:Quality System Oversight: Ensure compliance with FDA, ISO, EN, and MDR standards, leading audits, CAPA processes, and driving quality improvement initiatives.Data Analytics: Analyze field failure data to identify trends, make recommendations for design or process improvements, and reduce costs and service impact.Audits & Compliance: Host and manage internal and external audits, ensuring quality system adherence across global operations.Leadership & Mentoring: Lead a team, provide training, and foster a collaborative, high-performance culture. Drive continuous improvement across the quality system.Cross-Functional Collaboration: Work closely with departments like engineering, production, and customer service to resolve issues and improve quality and compliance.What you will need to be considered:Experience: 7+ years in quality management roles within the medical device industry; 3-5 years in quality auditing.Education: Bachelor’s degree in a relevant field.Certifications: Lead Auditor training for ISO 9001/ISO 13485, CQE or CQM certifications preferred.Skills: Strong knowledge of FDA regulations, ISO standards (13485, 14971), and experience with ERP systems like SAP. Proficiency in Microsoft Office tools.Leadership: Proven ability to lead and mentor teams, delivering high-quality results and driving cross-functional collaboration.What’s in it for you Competitive Compensation: Attractive salary and benefits, including healthcare, retirement plan, and more.Career Advancement: Access to ongoing training, leadership development, and internal growth opportunities.Work-Life Balance: Flexible work environment with minimal travel required (up to 20%).Impactful Role: Make a tangible difference in the quality of healthcare products, ensuring they meet the highest standards.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.Ready to make an impact Apply today and help us shape the future of medical technology at KARL STORZ.#LI-BL1
Full Time
1/14/2025
Bellingham, MA 02019
(33.5 miles)
Are you Looking to Advance Your Engineering Career andContribute to ImprovingHigh-Quality Products in a Highly Regulated Industry As aCNC Machining Process Developerat KARL STORZ U.S., you will be responsible for ensuring smooth product flow across work centers and addressing any technical machine shop issues. You will work closely with Manufacturing Engineering to develop, validate, and improve machining processes, tooling, fixtures, and CNC programs. Your role will be pivotal in troubleshooting, optimizing manufacturing processes, and supporting new product launches.Hours: 7:00 a.m. - 3:30 p.m., Monday through FridayLocation: Franklin, MAWhat you'll be doing:Collaboratingwith Manufacturing Engineering to develop and document machining processes and tooling.Creatingand maintainingCNC programs using Esprit CAM software.Creatingand maintainingthe fabrication data package, which may include, but is not limited to, operational drawings and instructions and tool and fixture drawingsTroubleshooting and resolvingissues related to processes, tooling, and machinery.Leading the validation and verification of new and updated machining processes and programs.Supporting continuous improvement projects, including Lean Manufacturing initiatives.Providingtechnical support for MRB and quality issues, implementing corrective actions as necessary.Participatingin cross-functional teams to optimize manufacturability and reduce costs.What you'll need to be considered:Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering or equivalent work experience.Proficiency in SolidWorks (CAD) and MS Office, especially Excel and Word.Knowledge and use of SAP is a plus.Experience with CNC machine setup, tooling, and run cycles.Knowledge of Statistical Process Control (SPC), GD&T, and Poke Yoke.Experience with Swiss turn machines, 5-axis mill/turn machining centers, and SMED practices.Familiarity with SAP and Esprit CAM software is a plus.Strong problem-solving, communication, and organizational skills.Ability to lift up to 50 lbs. and stand for extended periods.Willingness to work overtime as needed.Must be able to evaluate information objectively and make independent decisions.Must be able to travel and drive for company business as required.Knowledge of FDA Quality System Regulations, ISO 13485, and ISO 9001 (current revisions) is essential.Why Join Us Work in a dynamic, innovative manufacturing environment with the latest technology.Contribute to improving high-quality products in a highly regulated industry.Be part of a team focused on continuous improvement and lean manufacturing.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.Ready to make an impact Apply today and help us shape the future of medical technology atKARL STORZ!#LI-BL1
Full Time
1/9/2025
Bellingham, MA 02019
(33.5 miles)
Are you ready to take your CNC machining expertise to the next level Due to EXCEPTIONAL growth, KARL STORZ is seeking aSenior CNC Machinist/Programmerto join our dynamic team, specializing in the precision manufacturing of medical device components. In this role, you’ll leverage your programming and machining skills to produce high-quality parts that make a difference.Shift hours:6:00 a.m. - 2:30 p.m., Monday through FridayWhat you'll be doing:Set up and operate CNC lathes, mills, and Swiss-style machines to deliver flawless results.Create, edit, and optimize CNC programs under engineering direction.Troubleshoot machining challenges and ensure parts meet tight tolerances.Lead projects to improve processes through Lean manufacturing initiatives.Train and mentor junior machinists, sharing your expertise and driving team success.What you will need to be considered:5–10+ years of CNC programming and machining experience, including exotic metals like nitinol and stainless steel.Proven ability to read blueprints, inspect parts, and maintain GMP compliance.Advanced problem-solving skills for tooling, setup, and machine alignment.Experience with FDA QSR, ISO 13485, and ISO 9001 standards.A passion for precision, innovation, and collaboration.Why Join Us Be part of a cutting-edge team revolutionizing medical device manufacturing.Competitive compensation and benefits package.Opportunities for leadership, growth, and professional development.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.It's not just about the tools we createit’s about the lives we change, together.Make an impact where precision meets purpose. APPLY NOW TO JOIN OUR TEAM!#LI-BL1
Full Time
1/1/2025
Bellingham, MA 02019
(33.5 miles)
Are you someone who is looking for a new, fulfilling career and has 2-3 years of experience working with small, precision parts in a regulated environment, particularly in medical device manufacturing KARL STORZ U.S. has a GREAT opportunity for you!!We are seeking a skilled Hand Finisher Assembler to join our growing team at our Advanced Machining Center in Franklin, MA. In this role, you'll be responsible for assembling, polishing, and inspecting miniature precision medical instruments, ensuring they meet strict FDA regulations and quality standards.What you'll be doing:Assemble and finish mechanical components, following approved techniques.Perform polishing, deburring, heat treating, and testing of parts.Inspect parts for aesthetics, functionality, and quality compliance.Operate machines for tumbling, bead blasting, and cleaning.Use SAP for work orders, inventory, and shipment processes.What you will need to be considered for this position:High school diploma or equivalent.2–3 years’ experience in assembling precision medical products under FDA regulations.2-3 years' experience working with a microscope.Proficient in reading engineered drawings and basic computer functions (Microsoft Office, SAP).Ability to document and maintain accurate production records.Experience with heat treating, annealing, and hardness testing.Excellent manual dexterity and keen attention to detail.Ability to work independantly as well in a team-oriented environment.Strong communication skills and commitment to safety standards.TWI trained and certified (preferred).Ability to work required hours and/or overtime as needed.Capable of standing or sitting for extended periods and using polishing/deburring machines.What’s In It For You Competitive Compensation:Enjoy a strong salary and benefits package that rewards your hard work and experience.Career Advancement:Take advantage of opportunities for training and development, with potential for growth within the company.Leadership Impact:Lead a team, driving improvements in quality, efficiency, and safety, and make a meaningful impact on the company’s success.Dynamic Work Environment:Thrive in a fast-paced, collaborative atmosphere where your contributions directly affect production outcomes.Job Stability:Join a well-established company with a commitment to continuous improvement, providing you with long-term career stability.Work-Life Balance:Enjoy overtime options when necessary, while maintaining regular hours and a structured work environment.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.If you're looking for a hands-on, fast-paced role where precision and quality matter, we encourage you to apply today!It's not just about the tools we createit’s about the lives we change, together.#LI-BL1
Full Time
1/8/2025
Bellingham, MA 02019
(33.5 miles)
Are you Looking for an Opportunity to Work for a Company that Makes a Difference in People's Lives Join our team at KARL STORZ as aCNC Machinist/Setup Operator II, where you'll operate and set up CNC machines (lathes, mills, Swiss-style) to produce precision components. We specialize in machining medical device parts using exotic metals like nitinol, stainless steel, and nickel alloys.Shift: 3:30 p.m. - 12:00 a.m., Monday through FridayWhat you'll be doing:Set up and operate CNC equipment following layouts and blueprints.Inspect parts to ensure blueprint tolerances and record data.Edit CNC programs for optimal performance.Perform basic TPM (Total Productive Maintenance) activities.Collaborate on Lean process improvements and problem-solving tasks.What you'll need to be considered for this position:3–5+ years of CNC machining and setup experience.Proficient in blueprint reading and part inspection.Familiarity with GMP standards and machining medical device components is a plus.Strong attention to detail, technical skills, and a willingness to learn and grow.What’s in it for you Competitive pay and benefits.A dynamic and growth-oriented work environment.Opportunities to work on cutting-edge projects in medical device manufacturing.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.It's not just about the tools we createit’s about the lives we change, together.Ready to advance your career in precision machining APPLY TODAY!#LI-BL1
Full Time
1/8/2025
Bellingham, MA 02019
(33.5 miles)
Are you ready to take your CNC machining expertise to the next level KARL STORZ is seeking aSenior CNC Machinist/Programmerto join our dynamic team, specializing in the precision manufacturing of medical device components. In this role, you’ll leverage your programming and machining skills to produce high-quality parts that make a difference.Shift hours: 3:30 p.m. - 12:00 a.m., Monday through FridayWhat you'll be doing:Set up and operate CNC lathes, mills, and Swiss-style machines to deliver flawless results.Create, edit, and optimize CNC programs under engineering direction.Troubleshoot machining challenges and ensure parts meet tight tolerances.Lead projects to improve processes through Lean manufacturing initiatives.Train and mentor junior machinists, sharing your expertise and driving team success.What you will need to be considered:5–10+ years of CNC programming and machining experience, including exotic metals like nitinol and stainless steel.Proven ability to read blueprints, inspect parts, and maintain GMP compliance.Advanced problem-solving skills for tooling, setup, and machine alignment.Experience with FDA QSR, ISO 13485, and ISO 9001 standards.A passion for precision, innovation, and collaboration.Why Join Us Be part of a cutting-edge team revolutionizing medical device manufacturing.Competitive compensation and benefits package.Opportunities for leadership, growth, and professional development.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.It's not just about the tools we createit’s about the lives we change, together.Make an impact where precision meets purpose. APPLY NOW TO JOIN OUR TEAM!#LI-BL1
Full Time
1/8/2025
Bellingham, MA 02019
(33.5 miles)
Are you Looking for an Opportunity to Work for a Company that Makes a Difference in People's Lives Join our team at KARL STORZ as a CNC Machinist/Setup Operator II, where you'll operate and set up CNC machines (lathes, mills, Swiss-style) to produce precision components. We specialize in machining medical device parts using exotic metals like nitinol, stainless steel, and nickel alloys.Shift: 6:00 a.m. - 2:30 p.m., Monday through FridayWhat you'll be doing:Set up and operate CNC equipment following layouts and blueprints.Inspect parts to ensure blueprint tolerances and record data.Edit CNC programs for optimal performance.Perform basic TPM (Total Productive Maintenance) activities.Collaborate on Lean process improvements and problem-solving tasks.What you'll need to be considered for this position:3–5+ years of CNC machining and setup experience.Proficient in blueprint reading and part inspection.Familiarity with GMP standards and machining medical device components is a plus.Strong attention to detail, technical skills, and a willingness to learn and grow.What’s in it for you Competitive pay and benefits.A dynamic and growth-oriented work environment.Opportunities to work on cutting-edge projects in medical device manufacturing.Who we are:KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.It's not just about the tools we createit’s about the lives we change, together.Ready to advance your career in precision machining APPLY TODAY!#LI-BL1
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