Supplier Quality Engineer Position Available In South Central Connecticut Planning Region, Connecticut
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Job Description
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:
The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance
