Senior Specialist - Device Quality Engineering - Remote

Overview

The Senior Specialist - Device Quality Engineering will be responsible for supporting the development and commercialization of medical devices, ensuring compliance with applicable regulations and internal requirements.

In Short

• Independent support for medical device development and commercialization.
• Interaction with cross-functional teams at all organizational levels.
• Develop, document, and review compliance documentation.
• Provide guidance on medical device design controls.
• Support development of Design History Files and Risk Management.
• Audit and approve documentation for regulatory filings.
• Ensure compliance with regulatory and internal requirements.
• Participate in regulatory agency inspections.
• Work independently and effectively in a team environment.
• Contribute to policy and procedure development.

Requirements

• Bachelor’s degree in Science or Engineering with relevant experience.
• Extensive knowledge of medical device regulations.
• Experience in Risk Management (ISO 14971).
• Ability to work independently and in teams.
• Excellent technical writing and communication skills.
• Preferred: Lean Six Sigma certification.
• Preferred: Regulatory Affairs experience.
• Creative thinking and problem-solving skills.
• Ability to adapt to fast-paced environments.
• Experience in matrix organizations.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, dental, and vision coverage.
• Flexible work arrangements.