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

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance