Location:
San Diego, CA – Onsite
Schedule:
Standard Office Hours
Duration: 3-
Month Contract
Pay range:$40.00 - $44.00 per hour
This Quality Engineering position supports manufacturing and product quality activities within the Manufacturing/Operations (Mfg/Ops) Quality organization. The role focuses on sustaining manufacturing, continuous improvement, capacity expansion, and process/product validation. It involves cross-functional collaboration and application of regulatory standards (21 CFR 820, ISO 13485, etc.) to ensure product and process quality in a regulated environment.
Responsibilities
- Support product lifecycle quality engineering.
- Assist manufacturing with validation planning and transfer.
- Manage non-conformance and CAPA processes.
- Participate in technical discussions and risk-based decisions.
- Review equipment onboarding, calibration, and maintenance for GMP compliance.
- Review and ensure compliance of change control documentation.
- Identify and close compliance gaps efficiently and effectively.
- Use risk-based approaches for issue resolution.
- Ensure manufacturing processes comply with FDA/ISO requirements.
- Analyze and report quality data; develop data-driven recommendations.
- Provide updates and escalate issues as needed.
- Collaborate with cross-functional teams across multiple sites.
- Perform other assigned quality-related duties.
Desired Background
- Education: Bachelor’s degree in an engineering or scientific field.
- Experience:
- 2–4 years in quality assurance within a regulated industry.
- In-vitro diagnostic manufacturing experience preferred.
- Experience with quality systems (CAPA, NC, Change Management), PLM, ERP, MES tools.
- Familiarity with nanoimprint lithography/surface activation chemistry is a plus.
- Skills:
- Strong communication, problem-solving, and organizational skills.
- Collaboration with cross-functional and global teams.
- Ability to manage change and make compliance/business trade-off decisions.
- Proficient in data analysis and quality improvement methodologies.
- Knowledge of applicable regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD, CMDR).
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