Engineer, QA

Work Flexibility: Hybrid

Basic Function:

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.)

Technical Competencies

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.

Travel Percentage: 20%

R519140