Title: Engineer, Quality
Location: Westford, MA
Duration: 6 Month Assignment
Shift - 8AM - 4:30 PM
Description:
- The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
- This position will also support device complaint investigation and failure analysis as required.
- Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review.
- Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads.
- Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
- Lead complaint investigations on returned product. Manage corrective action and quality improvement activities.
- Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
Experience:
- 2–3 years minimum of Quality Engineering experience, preferably in Medical Device Manufacturing.
- Experience in Pharma or Electronics is acceptable.
- Relevant experience must be in a highly regulated industry.
- Should have experience working on and executing tasks for projects, risk review, CAPA, and problem solving.
Skills:
- Risk assessment review
- Corrective/Preventative Actions
- Inspection plan creation
- Documentation change management
- Problem solving/DMAIC
- Project management
- Time management
General Description of Work:
- This candidate will be working on several high-quality impacting projects at the Abbott Westford Manufacturing facility. They will be a part of our post-market Sustaining Quality Engineering team and support projects related to post-market updates to our products. This includes maintenance of risk documentation, MPIs, design change evaluations, and support of complaint investigations and analysis.
- This person will be expected to be prompt, organized, independent, and an aggressive problem solver. We need a candidate with a proven track record of coming up to speed quickly, a strong work ethic, and a dedication to supporting life-saving medical devices.
Consultants Eligible Benefits Upon Waiting Period:
• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
