Work Flexibility: Hybrid
Position Summary:
Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM quality issues, development of suppliers and ensuring that our external supply chain is capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison between OEM/ Stryker to drive effective continuous improvement as a result of the supplier base.
You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation.
You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of OEM/ meet our
requirements and continually meet and adapt to our product quality and regulatory.
What you will do:
This role will provide coaching and guidance to the OEM/CM team to ensure
compliance to technical, regulatory and Stryker requirements.
Act as liaison for customer groups on key compliance issues.
Provides leadership to the OEM/CM Team being responsible for the plant
metric reporting and local SME for OEM/CM Quality procedures &
processes.
Ownership and reporting on all quality issues associated with OEM/CM
suppliers within the assigned commodity. Ensure all Supplier related
material quality issues are effectively communicated.
Oversight of the OEM/CM material related processes which include:
Material Review Board to ensure Coordination of MRB activities with the
business unit to ensure the timely assessment of potential non-conforming
products.
Act as a point of Contact for OEM/CM Quality during External Audits and
Internal Audits as required.
Ensure Regulatory compliance in area of responsibility to GMP of all
medical regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
Develop structured communication channels with strategic sourcing,
identifying responsibility by OEM/CM.
Liaising with the Manufacturing and Quality groups and Business Units, in
assessing and addressing material quality issues.
Track OEM/CM quality performance measurement supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the OEM/CM quality team at the Monthly Business.
What you need:
- Honors Engineering or Science fields or equivalency.
- Minimum of 4 manufacturing environment.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Lead Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or
- comparable industry standards and regulatory requirements
- ASQ CQE/CQM/PE certification- Desirable
- Strong English skills
Travel Percentage: None
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What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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