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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits
Job description
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
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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