A class III medical device leader is looking to bring on a Senior Design Quality Engineer to their team full-time, on-site in Massachusetts.
Responsibilities:
- Oversee the design control process related to customer expectations and regulatory requirements for NPI and sustaining projects.
- Collaborate with Development and Engineering teams to implement design control requirements.
- Contribute to design and manufacturing engineering projects, ensuring DHF deliverables for FDA compliance are met.
- Review and approve CNs for design control within the documentation system.
- Represent design quality functions during the review and approval of designated design outputs.
- Be the SME for design control processes and Quality Engineering, including Risk Management, TMV, Statistics, Reliability Engineering, and PV.
Requirements:
- Bachelor's degree in Engineering with 8 years' experience, including medical device development control.
- Knowledge of Software Development Lifecycle, 21 CFR Part 820, ISO 13485, ISO 14971, and statistical analysis tools such as Minitab.
- Understanding and application of Gage R&R and Measurement System Analysis.
- Preferred experience in process validation, including IQ, OQ, PQ.
