Ensuring compliance to Supplier management activities identified by organization.
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 to facilitate root cause analysis and corrective actions of supplier quality issues.
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)
Evaluate Quality data to identify process improvement opportunities within the supply chain.
Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
Review of process and equipment Validation including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.
Prioritizing, reviewing, and delivering First Article Inspections FAIs for sustaining parts and development projects.
What you will need:Required Qualification:
B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Quality / Engineering / Manufacturing environment.
Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
Executes/implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively.
Proficient in MS Office Suite (including Word, Excel, Power Point etc).
Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
Preferred ASQ Certified Quality Engineer (CQE).
Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services.
Travel Percentage: 10%
Skills Required
- B.Tech (Electronics/Electrical/Mechanical) with 2-5 years in Quality/Engineering/Manufacturing
- Experience with PPAP for New Product Launches and production/manufacturing transfers
- Working knowledge of quality tools: PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poka-Yoke, Kaizen, Lean
- Apply systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) for NC & CAPA
- Execute/implement supplier quality processes and train suppliers
- Proficient in MS Office Suite (Word, Excel, PowerPoint)
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory)
- Review process and equipment validation including IQ, OQ, PQ, special process and test method validations
- Inspect and test materials, equipment, processes, and products to ensure quality specifications are met
- Prioritize, review, and deliver First Article Inspections (FAIs) for sustaining parts and development projects
- Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, EU MDD)
- ASQ Certified Quality Engineer (CQE)
- Excellent communication and influencing skills; ability to manage multiple tasks
- Commodity domain knowledge: technology and regulatory requirements related to product, system & services
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
Stryker Insights
What We Do
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 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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