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Engineer, QA - Raleigh, United States - Stryker
Description
Manufacturing Quality Engineer role is to implement a unified approach to Quality in Stryker with the intent to deliver high quality products and services in a manner that meets the high standards held by Stryker.
Responsibilities:
This role will provide support to the Site Quality team to ensure compliance to technical, regulatory and Stryker requirements.
Executing Change Managements & Manufacturing Changes associated with Machine moves, Process changes, validation updates.
Executing Production part approval process for any change request.
Good hands-on experience on Validation (Validation PSPs, EQ, MSA execution)
NC/ CAPA for internal Manufacturing issues (Clean, Pack, Label, Gage)
Driving Internal Continuous Improvement projects at Site.
Executing Gage Evaluation from QT's & focus on Gage/ fixture Updates & Development.
Reviewing & providing inputs on Supplier Material Certificates.
Ownership for site quality performance and measurement including KPI's and participate in supplier performance reviews.
Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and
corrections/corrective
action.
Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.
Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements.
Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
Professional Requirements:
B.Tech
(Electronics/Electrical/Mechanical)
with 4-7 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a must.
Supplier Quality Processes/ Tools
. Trains supplier in these tools effectively.
Commodity Domain Knowledge –
Strong Knowledge & understands technology, regulatory requirement related to product, system & services. Determine supplier technical abilities based on these knowledges.
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