Quality Assurance Technician

Thank-you for taking the time to read through this job posting. If this is a job you'd like to work, please submit your resume/application. Please TEXT me with Questions and/or Inquiries at 4 1 4 - 5 5 9 - 1 0 3 6 , Send Resume to j o y @ c s t a f f . c o m Thank you, Joy Meyer, Collaborative LLC.

QA Tech Position, Burlington MA .......................................................................................................

• Fulltime, 40 Hrs per Week
• Monday to Friday
• 7:30a to 4pm
• Pay is $21/hr

***Please note that this position is strictly dedicated as a Technician role. Candidates with advanced degrees or engineering experience will be considered overqualified for this specific scope of work.***

This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

MAIN RESPONSIBILITIES

• Perform first article incoming inspection of purchased components and inspection of production operations, including

documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.

• Document nonconformances as appropriate.
• Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Assist with or perform Gage R&R studies.
• Assist with the selection, installation and programming of precision measuring equipment.
• Create and maintain control plans for products and processes.
• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and

validations.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),

Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating

procedures, processes, and task assignments. Maintains positive and cooperative communication and collaboration with all

levels of employees, customers, contractors, and vendors.

Experience Details

Minimum 2 years 2-4 years’ experience.

• Previous experience in assisting with validations & qualifications,

Gage R&R, calibration, test methods, and NCMR dispositioning.

Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide

regulatory requirements.

Experience with optical measurement equipment, hand tools, gages, pressure, and force

gage testing and fixture design.

Training in blueprint reading and experience with sampling techniques.

Good communication and computer skills, including data analysis and report writing skills.

Prior medical device experience preferred.

ASQ CQT certification or equivalent preferred.

Experience working in a broader enterprise/cross-division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast-paced, changing

environment.

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at

multiple levels in the organization.

Multitasks, prioritizes, and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Please submit your resume highlighting relevant experience in shipping and receiving.

Job Requirements ...............................................................................................

• High School Diploma or Equivalent Required
• 6 Months in Similar Position Preferred
• Previous Experience Preferred
• Background Check

Please TEXT me (Anytime) with Questions and/or Inquiries at 4 1 4 - 5 5 9 - 1 0 3 6 (Call during business hours), Send Resume to j o y @ c s t a f f . c o m Thank you, Joy Meyer, Collaborative LLC.