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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
Location: 571 Silveron Blvd, Flower Mound, TX
Shift: Monday - Friday, day shift hours (flexible)
Summary:
The Quality Engineer Technician, Calibration Coordinator, will be responsible for managing the calibration program, ensuring compliance with industry regulations and company standards. In this role, you will track calibration schedules, coordinate external calibration services, maintain and update calibration procedures, and support internal and external audits. You will also collaborate with New Product Development (NPD) teams to ensure the existing toolset remains compatible with future products, as well as other tasks needed to support the business.
Additionally, you will be assisting the Quality Engineering team in developing, applying, revising, and maintaining quality standards for processing raw or returned materials and/or components into partially finished and/or finished products. Responsible to perform root cause product investigation and disposition product.
What You Will Do:
- Work as part of the Returns team to receive, investigate, and inspect incoming product.
- Maintain an accurate inventory of calibrated tools.
- Track and schedule calibrations using CERDAAC software & Agile database to ensure timely compliance.
- Coordinate with external calibration service providers and manage calibration-related documentation.
- Verify and maintain calibration and operation of all tools, maintain equipment logs, and complete maintenance reports accurately.
- Develop, update, and enforce calibration procedures to comply with ISO 13485:2016, FDA regulations, and NIST traceability requirements.
- Serve as the primary point of contact for internal and external auditors regarding calibration program compliance.
- Serve as the primary point of contact for all field-based personnel regarding calibration program escalations.
- Collaborate with NPD teams to assess tool compatibility with new products and recommend necessary updates.
What You Need:
Required:
- High School Diploma or equivalent
- 3+ years of experience in calibration, quality systems, or a similar role in the medical device or regulated industry
- Knowledge of ISO 13485, FDA regulations, and NIST traceability requirements
- Experience with troubleshooting and repair fundamentals
- Ability to work with and inspect very small objects and/or tools and component parts
Preferred:
- Associate of Science in Engineering or Engineering-related discipline
- Quality Assurance training
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. 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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