Quality Engineer

Job Description

We are seeking a Quality Engineer to join a leading medical device manufacturing organization. This role is responsible for ensuring compliance with quality systems, regulatory standards, and continuous improvement initiatives within a highly regulated environment.

Key Responsibilities:

-Support and maintain the Quality Management System (QMS) in compliance with FDA and ISO standards

-Lead and support CAPA, deviation investigations, and root cause analysis

-Ensure compliance with GMP, ISO 13485, and applicable regulatory requirements

-Participate in internal and external audits, including FDA inspections

-Drive continuous improvement initiatives using Lean and Six Sigma methodologies

-Review and approve validation protocols (IQ/OQ/PQ) and technical documentation

-Collaborate cross-functionally with Manufacturing, R&D, and Regulatory teams

-Support change control processes and risk management activities

Qualifications:

-Bachelor’s degree in Engineering or related field

-2+ years of experience in medical device or pharmaceutical manufacturing

-Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485

-Experience with CAPA, NCR, validation, and audits

-Proficiency in root cause analysis tools

-Bilingual (English/Spanish) is a plus

Key Skills:

-Strong analytical and problem-solving skills

-Attention to detail and compliance-driven mindset

-Excellent communication and documentation skills

-Ability to work in a fast-paced, regulated environment

Equal Opportunity Employer / Disabled / Protected Veterans

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The pay transparency policy is available here:

For temporary assignments lasting 13 weeks or longer, the Company 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.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

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.

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Company Description

This company offers growth and a great group of people to work with.

Full-time