Quality Engineer at Stryker

Gurugram, Haryana, India

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Quality / Engineering / Manufacturing environment
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/improves all supplier quality tools/Processes and trains suppliers in these tools effectively
Proficient in MS Office Suite (including Word, Excel, PowerPoint etc)
Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs)
Preferred: Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard/regulation) and EU's Medical Device Directive
Preferred: 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)
Preferred: Commodity Domain Knowledge – Strong knowledge & understands technology, regulatory requirements related to product, system & services
Preferred: Proven track record of leading successful process implementation projects

Responsibilities

Collaborate closely with the OEM/CM suppliers and internal stakeholders to support supplier performance across quality, service, and cost dimensions
Act as the primary liaison between Stryker and OEM/CMs to ensure suppliers consistently meet technical, regulatory, and business requirements
Manage and execute PPAP (Production Part Approval Process) activities for New Product Introductions (NPIs) and post-launch production, including manufacturing transfers and process stabilization
Partner with cross-functional teams during product development and design changes to ensure supplier readiness and adherence to quality deliverables
Lead structured problem-solving efforts (e.g., 8D, 5 Whys, DMAIC, Cause & Effect) to drive effective root cause analysis and corrective action implementation for supplier-related quality issues (NCs, CAPAs)
Promote and apply continuous improvement tools such as Lean, Six Sigma, Poka-Yoke (error-proofing), Measurement System Analysis (MSA), Statistical Process Control (SPC), and Process FMEA (pFMEA) across the supply base
Coordinate supplier-driven changes through formal change control processes to ensure seamless implementation and compliance
Review and approve supplier validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), special process validations, and test method validations
Manage First Article Inspections (FAIs) for both sustaining parts and development projects, ensuring alignment with engineering and quality requirements

Skills

Key technologies and capabilities for this role

PPAPSix SigmaSPCFMEALeanPoka-YokeMSADMAIC8D5 WhysKaizenRoot Cause AnalysisIQOQPQ

Questions & Answers

Common questions about this position

What is the work arrangement for this Quality Engineer role?

The position offers hybrid work flexibility.

What qualifications and experience are required for this position?

Candidates need a B.Tech in Electronics, Electrical, or Mechanical engineering with 2-5 years of experience in Quality, Engineering, or Manufacturing. Required skills include working knowledge of quality tools like PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, and Lean Manufacturing, plus proficiency in MS Office Suite and strong interpersonal skills for cross-functional teams.

What is the salary or compensation for this role?

This information is not specified in the job description.

How much travel is required in this position?

The role requires up to 20% travel.

What preferred qualifications will make my application stand out?

Preferred qualifications include understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820), excellent communication skills, ASQ Certified Quality Engineer (CQE), and commodity domain knowledge with a proven track record in process implementation projects.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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