Quality Engineer I: CAPA, NCRs & Process Validation

RedBrick Staffing; Irvine (CA); On-site; USD 60,000 - 85,000; Full time

Job summary

RedBrick Staffing is seeking a technically minded QA/Regulated Documentation Assistant in Irvine, CA to support quality systems and manufacturing documentation in a fast-paced medical device environment.

You will draft and route quality records, assist CAPA investigations, and maintain controlled documents within the eQMS, ensuring compliance with ISO 13485 and FDA regulations. This role offers growth opportunities and on-site collaboration with cross-functional teams in a regulated setting.

Qualifications

• Bachelor's degree in Engineering or a related field.
• 1+ years of relevant industry experience.
• Comfortable in a regulated environment (ISO 13485, 21 CFR Part 820/QMSR, 21 CFR Part 1271).
• Self-driven and a team player with an eagerness to develop professionally.
• Ability to help support cross-functionally.

Responsibilities

• Draft & route NCRs from cradle to grave.
• Support CAPA investigations.
• Assist doc control in our eQMS: COs, periodic reviews, DMR/DHF filing.
• Support internal audits.
• Assist CMO process development: document technical reviews, track open items.
• Support process validation (IQ/OQ/PQ): protocol execution, data collection, report creation.
• Develop & maintain instructions & mfg. procedures.
• Support incoming inspection & FPL upkeep.
• Support DDFs.
• Other duties as assigned.

Skills

Regulated environment experience

Team collaboration

Documentation skills

Education

Bachelor's degree in Engineering or similar

Tools

eQMS

Job description

RedBrick Staffing is seeking a technically minded QA/Regulated Documentation Assistant in Irvine, CA to support quality systems and manufacturing documentation in a fast-paced medical device environment.

You will draft and route quality records, assist CAPA investigations, and maintain controlled documents within the eQMS, ensuring compliance with ISO 13485 and FDA regulations. This role offers growth opportunities and on-site collaboration with cross-functional teams in a regulated setting.