Engineer, QA

4 weeks ago

Raleigh, United States Stryker Full time

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. Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.) Supplier Quality Processes/ Tools

- Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc. Executes/ Masters & implements/ improve all supplier quality tools/ Processes

. 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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