Quality Engineer

Quality Assurance Manager

Work Flexibility: Hybrid

What You Will Do:

Ownership for site quality performance and measurement including KPIs and participate in supplier performance reviews.

Support quality issues with site & partner with Internal Customers; lead effective supplier containment and corrections/corrective actions.

Hands on experience of PPAP associated with New Product Launches and Management of Production cycles thereafter (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.

All potential onePLM change control activities and MasterControl activities.

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).

What You Will Need:

Required qualification: B.Tech (Electronics/Electrical/Mechanical/Biotech) with 3-7 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a plus. Trained on Trackwise enterprise system, PLM would be an advantage. Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.).

Preferred Qualification:

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: 10%