Job Information
Stryker Engineer, QA in Gurugram, India
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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.
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 actions
Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.
Ensuring compliance to Supplier Control activities identified by organization.
Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
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.
Evaluating Quality data to identify process improvement opportunities within the supply chain.
Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders
Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA)
Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
Professional Requirements:
B.Tech (Electronics/Electrical/Mechanical) with 4-6 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a must.
Trained on Trackwise enterprise system, PLM would be an a1dvantage.
Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)
Technical Competencies:
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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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 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.