Rapid growth and increasing technical requirements have necessitated adding to the team in the Billerica MA area. The ideal candidate for this position must have experience in the Medical Device Manufacturing Industry and a dynamic personality. The Quality Engineer will support the Operations Organization with quality improvement and corrective/preventative action programs with other departments in a cross functional environment.
Our client is a leading Medical Device Manufacturer specializing in electromechanical products is in search of an experienced Manufacturing Quality Engineer.
- Utilize teams to accomplish improvement projects. Facilitate teams to successful completion of projects and guide teams through the team building process.
- Manage / Perform Validations of all Equipment & Special Processes
- Manage CAPA Process & Continuous Improvement
- Determine Optimal Inspection Plans, Sampling Plans, and Gaging Methods with focus on improvement
- Internal Auditing, Reporting, Improvement
- Lead multi-discipline product quality teams and participate in New Product Introduction projects.
- Develop and implement quality improvement
- Ability to lead product quality investigations to a successful conclusion.
- Investigate causes of quality and yield problems identified in Incoming Inspection, Manufacturing processes and Final QA
- Collect, analyze and disseminate quality data throughout the
- Participate in Change Control Review and Material Review Board activities.
- Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System
- Bachelor's degree Engineering is required
- Minimum 5 years related experience in a regulated environment, preferably medical device
- Excellent written, verbal, time management and interpersonal communications skills
- ASQ Certified Quality Engineer desirable
- Familiar with mechanical and electronic equipment
- Familiar with Statistical Analysis to analyze data and identify trends
- Experience with ISO 9001, ISO 13485, 15014971 and FDA QSR for Medical Devices
- Competitive and Leading Salaries for Qualified Candidates
- Paid Education/ Tuition Reimbursement
- Vacation Package
- Benefits Wages
- Please apply to learn more!