Manpower Engineering is partnering with a leader in medical device manufacturing for an Operations Senior Quality Engineer.
Job Title: Operations Senior Quality Engineer
Location: Minneapolis, MN (100% onsite)
Pay: $45 - $68/hour
Duration: 6-9+ month, Contract to Hire
Job Function Summary:
|
The Interventional Urology Operations Sr. Quality Engineer is responsible for supporting and maintaining quality compliance and will recommend and implement process improvements within US Operations. In all actions, they will demonstrate a primary commitment to patient safety and product quality.
|
Primary Duties and Responsibilities:
- Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues.
- Recommend and implement quality improvements and processes to ensure regulatory compliance and promote continuous improvement.
- Conduct and document root cause investigations of non-conforming processes and products.
- Facilitate Material Review Board meetings.
- Participate in or lead Corrective and Preventive Actions as appropriate.
- Review sampling techniques/methods/rationale and test methods to ensure appropriateness.
- Review quality content in change control for products and processes.
- Review and author validation documents and validate processes.
- Initiate Change Requests to update documentation and processes.
- Perform data analysis; write summary reports and other technical memoranda.
- Coordinate and support calibration activities - including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed.
- Maintain applicable QMS instructions.
- Support and participate in Internal and External Audits
Requirements:
- Bachelor’s degree in a relevant science or engineering discipline.
- A minimum of five years related experience in medical device manufacturing preferred
- Experience with process validation, change control systems, sample size determination, FMEA, and Gage R&R.
- Knowledge of various statistical techniques.
- Analytical problem-solving skills.
- Excellent data analysis skills and proficiency using statistical tools (e.g. Minitab).
- Ability to successfully work within a team-based environment.
- Ability to effectively manage multiple projects and priorities.
- Effective computer skills including knowledge of Microsoft Office (Word, Excel, PowerPoint).
|
Knowledge, Skills and Abilities: |
- Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
- Ability to apply standard techniques, procedures, and criteria to perform assigned tasks.
- Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the operations quality function.
- Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
- Familiarity with geometric dimensioning and tolerancing.
- Experience performing internal audits.
|
Benefits:
Upon completion of waiting period consultants are eligible for:
• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long-Term Disability Insurance
• Accrued Sick Pay
• 401(k)
