Quality Engineer, OEM/CM

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team 

What you will do?

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’s 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/CM’s and Stryker to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and OEM/CM’s in support of quality issues; provide technical support for activities related to 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/CM’s to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.

This role will provide coaching and guidance to the OEM/CM’s team to ensure compliance to technical, regulatory and Stryker requirements.

Roles & Responsibilities

• Ownership for OEM/CM quality performance and measurement including KPI’s and participate in supplier performance reviews.
• Support quality issues with OEM/CM’s & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions

• Provide support to Internal/ External Customer groups on compliance issues related to assigned OEM/CM’s.

• Support External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)

• Participate in 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.

• Maintain structured communication channels with strategic sourcing, identifying responsibility by OEM/CM.

• Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned OEM/CM.

• Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions

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• Support continuous improvement activities focusing on OEM/CM quality

• Participate as required in SCRB in conjunction with key stakeholders

• Support the assessment of OEM/CM supplier changes

• Participate in supplier audit program – planning, execution and closure

• Participate in supplier reviews for assigned OEM/CM suppliers as required

• Participate in cross functional projects

• Support the developments and approval quality assurance agreements with OEM/CM suppliers.

What you will need?

• Bachelors degree in Engineering or Science fields or equivalency.
• 0 to 2 years of experience in manufacturing environment or equivalent.
• Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
• Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com