Senior Quality Engineer Job in Stryker

Why Join Stryker?

Looking for a company that recognizes and values your unique talents? Join Stryker and experience our award-winning culture.

We offer a comprehensive total rewards package, including bonuses, healthcare, insurance benefits, retirement programs, wellness initiatives, and performance awards. We also provide various social and recreational activities tailored to each location.

Job Description

Key Responsibilities:

• Ensure compliance with supplier control activities as outlined by the organization.

• Lead PPAP (Production Part Approval Process) for new product launches and manage production cycles post-launch, including manufacturing transfers.

• Collaborate with cross-functional teams to develop new products or make changes to existing ones to meet customer requirements.

• Apply systematic problem-solving methodologies (5Why, DMAIC, 8D, and C&E) to resolve quality issues, manage NC (non-conformance) and CAPA (corrective and preventive actions), and drive root cause analysis.

• Promote continuous improvement initiatives such as Lean, Six Sigma, Poka-Yoke (error proofing), MSA (measurement system analysis), SPC (statistical process control), and pFMEA (process failure mode and effects analysis).

• Analyze quality data to identify opportunities for process improvement across the supply chain.

• Coordinate change management and control with suppliers, ensuring the successful implementation of changes.

• Oversee process and equipment validation (IQ, OQ, PQ), special process validations, and test method validations.

• Inspect and test materials, equipment, processes, and products to ensure adherence to quality specifications.

• Prioritize and deliver First Article Inspections (FAIs) for both sustaining and development projects.

What You Need:

Must-Have Skills:

• B.Tech (Electronics, Electrical, or Mechanical) with 5-9 years of experience in a quality, engineering, or manufacturing environment.

• Strong knowledge of quality tools such as PPAP, Six Sigma, SPC, FMEA, control plans, root cause analysis, Poka-Yoke, Kaizen, and lean manufacturing.

• Ability to implement and improve supplier quality tools and processes and effectively train suppliers.

• Proficient in MS Office Suite (Word, Excel, PowerPoint, etc.).

• Strong interpersonal skills for working with cross-functional teams (engineering, R&D, manufacturing, and regulatory affairs).

Good-to-Have Skills:

• Understanding of medical device regulatory compliance (ISO 13485, CFR 820, or similar standards/regulations) and the EU's Medical Device Directive.

• Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the quality function across teams.

• ASQ Certified Quality Engineer (CQE) certification.

• In-depth knowledge of technology and regulatory requirements related to products, systems, and services.

Health Benefits:

• Medical, dental, and vision insurance

• Prescription drug coverage

• Critical illness, accident, and hospital indemnity insurance

• Personalized healthcare support, wellness programs, and tobacco cessation

Financial Benefits:

• Health Savings Account (HSA) and Flexible Spending Accounts (FSAs)

• 401(k) plan with company match

• Employee Stock Purchase Plan (ESPP)

• Life insurance and short-term disability insurance

About Stryker:

Stryker is a global leader in med-surg, neurotechnology, and orthopedics, dedicated to improving patient and healthcare outcomes. Each year, we impact over 150 million patients worldwide. Depending on role requirements, employees in sales and field roles may be required to obtain vaccinations to access customer accounts as an essential part of their role.