at Stryker
Location
Irvine, California
Compensation
$59k–$81k USD
Type
full time
Posted
Yesterday
Market range · company + function + seniority
p25 · target · p75 · n=96
Posted $81k · below the band
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Schedule: Monday - Friday, 6:00am- 2:30pm, OT as needed by the business
What You'll Do
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
What You'll Need
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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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