Staff NPD Quality Engineer
$109,000–$174,800 year
On-siteRaynham, Massachusetts, United States
Job Summary
Serve as lead quality engineer on cross-functional new product development projects, driving design transfer activities with internal and external stakeholders. Leverage expertise in statistical techniques, GD&T, and process validations to support new product introductions while leading root cause investigations and risk management strategies. Provide leadership in the Quality System, overseeing corrective actions, product complaints, post-market surveillance, and audits, while communicating regulatory requirements across Product Development, Regulatory, and Supply Chain teams. Mentor others in technical capabilities and ensure compliance with Federal, State, and Company regulations.
Required Qualifications
- Bachelor's degree in Engineering or related technical/scientific field
- 6 or more years related experience
- Understanding of new product introduction processes
- Expertise in process qualifications/validations
- Strong knowledge of GD&T and inspection methodologies
- Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards)
- Advanced knowledge of Quality Engineering/Scientific Method techniques and principles
- Demonstrates a strong understanding of all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audit
- Familiarity with manufacturing processes and controls
- Ability to effectively collaborate and communicate with internal and external partners
- Demonstrate strong interpersonal, organizational, and verbal/written communications skills
- Experience working in a regulated environment
- Knowledge of, and experience with, applicable standards, GxP requirements and regulations
Desired Qualifications
- Experience with technical mentorship
- Managing co-ops/contractors
- Accelerating
- Agility
- Jumps
- Coaching
- Communication
- Compliance Management
- Continuous Improvement
- Data Savvy
- Disaster Recovery (DR)
- Econometric Models
- Issue Escalation
- Problem Solving
- Product Improvements
- Quality Control (QC)
- Quality Control Testing
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Environment
- Researching
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.