Senior Quality Engineer — Regulated MedTech Leader

Fidelis Companies; Virginia (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical device company in Virginia is seeking a Senior Quality Engineer to lead cross-functional initiatives ensuring compliance with regulatory and business objectives. The ideal candidate will have a degree in Engineering and experience in Quality Engineering within the medical device industry. Responsibilities include driving verification and validation efforts, managing design control, and ensuring product safety and efficacy.

Qualifications

• Bachelor’s degree in Engineering or a related scientific field.
• Experience in Quality Engineering within the medical device, biologics, or tissue combination product industry.
• Working knowledge of FDA regulations and ISO standards.
• Experience leading Design Control, Risk Management, and V&V activities.

Responsibilities

• Act as the lead Quality Engineering representative on multifunctional teams.
• Partner with teams to ensure compliance with regulatory requirements.
• Play a critical role in risk management throughout the product lifecycle.
• Lead design control activities and participate in V&V efforts.
• Ensure ongoing process control and monitoring.

Job description

A leading medical device company in Virginia is seeking a Senior Quality Engineer to lead cross-functional initiatives ensuring compliance with regulatory and business objectives. The ideal candidate will have a degree in Engineering and experience in Quality Engineering within the medical device industry. Responsibilities include driving verification and validation efforts, managing design control, and ensuring product safety and efficacy.