Sr. Quality Engineer - Quality Management Systems Job in Stryker

Why Join Stryker?

Looking for a workplace that recognizes and values your unique skills? Join Stryker and be part of our award-winning culture.

We proudly offer a comprehensive total rewards package, including bonuses, healthcare, insurance benefits, retirement plans, wellness programs, and performance awards. You ll also have access to social and recreational activities tailored to your location.

Job Description

What You Will Do:

• Ensure compliance with Quality Management Systems (QMS) in line with internal and external regulatory requirements, including but not limited to FDA, ISO, MDD, FGO EU, and country-specific regulations.

• Contribute to the development of an optimized QMS that aligns with corporate, divisional, and global QMS requirements.

• Assess and quantify QMS support requirements, ensuring the right structure is in place for effective service delivery.

• Promote Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within the Quality department.

• Identify and implement opportunities for continuous improvement to enhance the efficiency and effectiveness of QMS processes.

• Develop and deliver QMS-related training and compliance programs for the team.

• Assist in the development, maintenance, and continuous improvement of QMS policies, procedures, and systems.

• Implement best-in-class QMS practices, benchmark against industry leaders, and ensure alignment with regulatory requirements.

• Ensure QMS accurately reflects actual business activities and supports New Product Introduction (NPI) needs.

• Contribute to the development or modification of regional/local QMS in a project environment.

• Participate in IT discussions, offering insights from a QMS perspective, and contribute to SRS/URS activities as needed.

• Support the business during audits, providing insights into system functionality.

What You Need:

Required:

• B.Tech (Electronics, Electrical, or Mechanical) with 5-7 years of experience in supplier quality.

• Knowledge of ISO 13485, FDA, EUMDR, and regional medical device regulatory requirements.

• Strong communication skills to effectively share information with team members, leaders, management, and suppliers.

• Experience supporting third-party inspections (FDA, notified body, etc.) within the medical device industry.

• Understanding of quality systems and web-based interactions.

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

• Proven ability to execute and lead projects, with a strong understanding of project stages.

• Proficiency in improvement methods and processes.

Preferred:

• Understanding of medical device regulatory compliance (ISO 13485, CFR 820, or equivalent).

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

• ISO 13485 Lead Auditor certification or equivalent.

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, short-term disability insurance

About Stryker:

Stryker is a global leader in MedSurg, neurotechnology, and orthopedics, helping improve patient and healthcare outcomes. Every year, we impact over 150 million patients globally. Depending on role requirements, employees may need to obtain vaccinations as an essential function of their role when accessing customer accounts.