Location
India | India
Job description
Job Description
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.
- Support and execute on cost optimization activities e.g. part certification, Inspection reduction.
- Support Sites with root cause analysis on defective parts and critical quality issues e.g. Escape, Commercial Hold, Product Field Action
- 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.
- 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.
- Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders
- 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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Travel Percentage: 20%
Job tags
Salary
