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Quality Manufacturing Engineer - Medical Device
Mid-level position which supports manufacturing quality & continuous improvement
This company is rated one of the top 5 fastest growing companies in NH
About Our Client
The global company has multiple locations across North America and focuses on disposable surgical devices for the health care industry. These single-use medical devices are generally products of plastics & injection molding. The company's customers consist of some of the top names in the healthcare & medical device industries.
The Rochester NH location has now grown to 160 employees and, despite a rapid growth period, still promotes a small company atmosphere where staff roll up their sleeves and wear many hats. The entire company meets with the Senior Leadership team on a weekly basis to ensure company objectives are transparent and attainable.
- Monitoring and improvement of product quality.
- Defect, scrap and rework prevention.
- Continuous improvement of and adherence to Quality Management System.
- Control, document, evaluate and disposition nonconforming materials.
- Supervise Quality Inspectors/Technicians and Document Control personnel.
- Investigate, document and communicate customer complaints. Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements
- Supplier Quality evaluation, monitoring, and improvement.
- Review and approve validation activities.
- Support Design and Design Transfer activities as needed.
- Sterilizations for both ETO and Gamma Radiation in accordance with the appropriate standards.
The Successful Applicant
- Technical Bachelor's degree is required, BS in engineering is preferred.
- Minimum 1 year of Quality or Engineering experience within a manufacturing setting. Medical device is preferred.
- Plastics & Injection molding experience preferred.
- Local candidates only, relocation is not offered.
- Working knowledge of the ISO13485 QMS and FDA Quality System Regulations.
What's on Offer
- Excellent benefits package
- Great exposure to the medical device industry, working with industry leaders
- Employee socials and initiatives throughout the year
- 10% quarterly bonuses
- On-site gym
- Weekly meetings with Senior leadership
- Open door policy with the President/CEO
- Growth and development role