Supplier Quality Engineer

North Haven, Connecticut Supply Chain 26 days ago

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Job Summary:
Seeking an experienced Quality Engineer to lead and support supplier quality activities in the medical device industry, ensuring compliance with ISO 13485 and 21 CFR 820 standards.

Job Requirements:

  • Bachelor’s Degree in Engineering

  • 4+ years of experience in the medical device industry

  • Knowledge of ISO 13485 and 21 CFR 820 regulatory requirements

Preferred Skills:

  • Experience with validation protocols, TMV, PPAP, and CAPA

  • Familiarity with Quality Management Systems (QMS)

  • Proficiency in developing and implementing Quality Plans, Control Plans, and FMEAs

  • Experience managing contract manufacturers (CMs) and suppliers

Job Responsibilities:

  • Lead and support supplier change requests (SCR) and associated quality activities

  • Review and approve validation documentation, TMV, PPAP, and CAPA

  • Collaborate with internal teams and suppliers to establish and maintain quality assurance systems

  • Develop and maintain Quality Plans, Control Plans, and FMEAs for new and existing suppliers

  • Ensure compliance with applicable medical device regulations and standards



Pay Details: $45.00 to $56.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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