Summary: Seeking a Quality Engineer to develop and support manufacturing documentation, equipment qualifications, and process validations in a regulated medical device environment.

Requirements:

Bachelor's degree 1-5 years of experience in manufacturing and quality engineering Experience in metal casting, CNC machining, metal finishing, or production automation Experience in medical device work environments

Preferred Skills:

Knowledge of FDA and European regulatory environments Background in validation and CAPA processes Bio/medical and manufacturing background

Responsibilities:

Develop, write, review, maintain, and revise manufacturing documentation Support development and execution of equipment qualifications (URS/FAT/SAT/IQ) Support development and execution of process validations (OQ/PQ/PV) Develop validation deliverables like CSV-E and Engineering Studies Assess, develop, write, execute, and review Test Method Validations (TMVs) Update relevant Process Risk Documentation (pRAS, pFMEA, FMCA) Partner with cross-functional teams for validation strategy and production transitions

Pay Details: $36.00 to $48.00 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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.