Quality Engineer

We are seeking an experienced Quality Engineer to support and drive quality initiatives across Operations, Manufacturing Engineering, R&D, and Quality teams. This role is responsible for leading investigations into in-market defects, conducting root cause analysis, managing CAPA activities, and resolving process nonconformances within a regulated manufacturing environment. The Quality Engineer will lead continuous improvement efforts using tools such as SPC and Six Sigma (5S, PFMEA, Control Plans, Value Stream Mapping), support change control and quality system processes, and ensure compliance with ISO 9001 and / or ISO 13485 and 21 CFR Parts 210 / 211 and / or 820. The ideal candidate holds a bachelor’s degree and brings 5+ years of quality experience in pharmaceutical, biotechnology, or medical device manufacturing, along with strong technical documentation, risk management, and cross-functional collaboration skills.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

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We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants : Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Additional Skills

MUST COME FROM THE PHARMACEUTICAL AND / OR MEDICAL MANUFACTURING INDUSTRY