Job ID: LA841924528
Location: Branford, CT
Category: Engineering
Employment Type: Permanent
Date Added: 05/28/2025
Senior Quality Engineer – Med Device (Class II or III) | $80,000 – $130,000 | Monday–Friday, Day Shift, Onsite in Branford CT | Direct Hire
What Matters Most
• Competitive pay of $80,000–$130,000 annually plus additional compensation
• Schedule: Monday – Friday | 8:00 AM – 5:00 PM (flexible)
• Location: Branford, CT
• Direct hire opportunity with career growth and long-term stability
• Competitive pay of $80,000–$130,000 annually plus additional compensation
• Schedule: Monday – Friday | 8:00 AM – 5:00 PM (flexible)
• Location: Branford, CT
• Direct hire opportunity with career growth and long-term stability
Job Description
• Join a growing U.S.-based medical device manufacturer with a mission to save lives
• Lead and support quality initiatives for Class III medical devices in a cGMP environment
• Partner cross-functionally to resolve manufacturing and supplier quality issues
• Drive process improvements and ensure compliance with FDA and ISO regulations
• Play a critical role in maintaining product reliability, safety, and regulatory readiness
• Join a growing U.S.-based medical device manufacturer with a mission to save lives
• Lead and support quality initiatives for Class III medical devices in a cGMP environment
• Partner cross-functionally to resolve manufacturing and supplier quality issues
• Drive process improvements and ensure compliance with FDA and ISO regulations
• Play a critical role in maintaining product reliability, safety, and regulatory readiness
Responsibilities:
• Lead investigations and CAPA related to nonconforming material and production issues
• Provide quality oversight on process qualifications, verifications, and validations
• Represent the Quality team in supplier audits and manage supplier quality performance
• Support design controls, risk assessments, and quality documentation for R&D projects
• Contribute to internal/external audit readiness and continuous improvement efforts
• Lead investigations and CAPA related to nonconforming material and production issues
• Provide quality oversight on process qualifications, verifications, and validations
• Represent the Quality team in supplier audits and manage supplier quality performance
• Support design controls, risk assessments, and quality documentation for R&D projects
• Contribute to internal/external audit readiness and continuous improvement efforts
Qualifications and Requirements:
• Bachelor’s degree required; Engineering discipline strongly preferred
• 5+ years of quality experience in the medical device industry (Class II or III required)
• Strong working knowledge of FDA QSR Part 820, ISO 13485, ISO 14971, and EU MDD/MDR
• ASQ certification and/or Six Sigma/Lean credentials preferred
• Skilled in quality systems, risk management, and supplier quality oversight
• Bachelor’s degree required; Engineering discipline strongly preferred
• 5+ years of quality experience in the medical device industry (Class II or III required)
• Strong working knowledge of FDA QSR Part 820, ISO 13485, ISO 14971, and EU MDD/MDR
• ASQ certification and/or Six Sigma/Lean credentials preferred
• Skilled in quality systems, risk management, and supplier quality oversight
Benefits and Perks:
• $80,000 – $130,000 annually
• Medical, dental, and vision benefits
• Excellent culture with summer Fridays, strong team, paid holidays and generous PTO
• Training and opportunities for career advancement – Position is open because of promotion
• $80,000 – $130,000 annually
• Medical, dental, and vision benefits
• Excellent culture with summer Fridays, strong team, paid holidays and generous PTO
• Training and opportunities for career advancement – Position is open because of promotion
Your New Organization:
Join a respected, U.S.-based medical device company known for its innovation and mission-driven culture. This team blends the agility of a start-up with the structure of a global manufacturer, offering a collaborative environment focused on passion, ownership, and integrity.
Join a respected, U.S.-based medical device company known for its innovation and mission-driven culture. This team blends the agility of a start-up with the structure of a global manufacturer, offering a collaborative environment focused on passion, ownership, and integrity.
Your Career Partner:
The Reserves Network, a veteran-founded and family-owned company, specializes in connecting exceptional talent with rewarding opportunities. With extensive industry experience, we are dedicated to helping you achieve your professional goals and shine in your field. The Reserves Network values diversity and encourages applicants from all backgrounds to apply. As an equal-opportunity employer, we foster an environment of respect, integrity, and trust in every aspect of employment.
