More jobs:
Quality Control Technician II - 1st Shift
Job in
Irvine, Orange County, California, 92616, USA
Listed on 2026-07-17
Listing for:
Stryker
Full Time
position Listed on 2026-07-17
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA, Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Quality Assurance Specialist
Work Flexibility:
Onsite
Schedule:
Monday - Friday, 6:00am- 2:30pm, OT as needed by the business
- Serve as the quality subject matter expert for product and process quality standards.
- Ensure compliance with cGMPs and regulatory requirements (FDA, BSI, TUV, and other medical device agencies).
- Act as the first point of contact for daily production line quality issues.
- Investigate product and process concerns, identify root causes, and support corrective actions.
- Partner with Quality Engineers and cross-functional teams to reduce risk and improve processes.
- Deliver defect awareness and quality training to production associates.
- Support the management and disposition of non-conforming materials and products.
- Segregate and contain product when quality discrepancies are identified.
- Conduct audit readiness checks and support internal quality audits.
- Monitor, trend, and analyze key quality metrics and performance data.
- Review customer complaints and support timely investigations and resolutions.
- Assist in preparing quality reports and periodic reviews.
- Review calibration certificates and quality documentation.
- Perform basic microbiology sampling and testing.
- Communicate quality concerns, trends, and watchouts to manufacturing teams.
- Support Environmental Health & Safety (EHS) initiatives and report safety concerns.
- Maintain compliance with all site and corporate Quality Management System requirements.
- Provide support during equipment failures, process interruptions, shutdowns, and special projects
Minimum Qualifications
- High school diploma or equivalent
- 2 years of production experience in a regulated environment.
Preferred Qualifications
- 1–2 years of Quality Assurance or related experience.
- Degree or certificate in Engineering, Science, or Business.
- Understanding of GMP/cGMP-regulated manufacturing environments.
- Knowledge of statistics and quality tools.
$28.23 - $38.74 USD Hourly
Travel Percentage: 0%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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