Quality Engineer (Direct Hire)
Devens, MA
Job Requisition: 6995.1
Description for Quality Engineer:
As the Quality Engineer you will be a hands-on engineer involving metal additively manufactured parts. Will have oversight of production related medical device quality projects from concept to shipping. Will include a large amount of validation work for new manufacturing lines. Hands on role on the floor, managing production related issues.
Responsibilities for Quality Engineer:
- Lead the FDA medical product development for the Quality Management System.
- Ensure the IQ, OQ, and PQ process meets customer expectations and is integral to Quality Management System.
- Develop, communicate, and implement Quality Standards.
- Assist the Quality Engineering Manager in assuring the QMS conforms to the customer, internal, industry (ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
- Assure Inspecting and testing materials, equipment, processes, and products meet quality specifications.
- Collaborate to develop and implement quality and process controls and improvements.
- Assure that calibration methods meet customer requirements and industry standards.
- Investigating and troubleshooting product or production issues
- Lead the inspection of manufactured parts, issue non-conformance reports, and facilitate the disposition of MRB hardware and corrective action tasks.
Requirements for Quality Engineer:
- Bachelor's degree in engineering or a related field is required
- Knowledge of medical product quality management qualification systems
- 1-2+ years experience of IQ, OQ, and PQ process
- 2+ years of experience in medical product development and Quality System creation
- 2+ years of experience in Quality Assurance/Quality Control
- First Article and inspection method creation
- Knowledge of 13485 Quality Management System
- Knowledge of GMP, FDA QSR, and MedAccred requirements
- Root Cause Analysis, Data analysis, and Statistical Process Control
