Senior Quality Engineer

Reposted 6 Days Ago
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Tijuana, Baja California
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
As a Senior Quality Engineer, you will manage supplier quality systems, drive improvements, and ensure compliance with regulatory standards in collaboration with suppliers and internal teams.
Summary Generated by Built In
Work Flexibility: Onsite

What you will do

In this role, you will support both internal quality processes and external supplier interactions, ensuring that finished goods and manufacturing sites consistently meet Stryker’s high standards for quality, compliance, and continuous improvement. You will collaborate closely with Finished Goods Operations, Manufacturing, and Quality teams, while also engaging with selected external suppliers to drive alignment on quality expectations and product performance.

Key Responsibilities:

  • Serve as the main liaison between Stryker and OEM/CM suppliers, driving effective continuous improvement initiatives. Provide technical support for supplier quality system assessments and performance evaluations.

  • Ensure product and process quality within internal manufacturing and operations teams, supporting investigations, non-conformances, and corrective actions.

  • Collaborate with external finished-goods suppliers to maintain product quality and compliance with Stryker’s standards.

  • Monitor and report key quality metrics (KPIs), supporting Monthly Business Reviews and continuous improvement initiatives.

  • Provide technical support on material reviews, change management, and regulatory compliance activities.

  • Partner cross-functionally with Quality, Operations, and Procurement to maintain robust quality systems and documentation.

What you need

Required:

  • Bachelor’s degree in Engineering, Quality, or a related technical field.

  • 2 to 5 years of experience in Quality Engineering or Quality Systems within a regulated industry.

  • Strong communication skills and the ability to work effectively with cross-functional teams and external partners.

  • Knowledge of regulatory standards (e.g., FDA, ISO 13485, GMP).

Preferred:

  • Experience in the medical device industry or other regulated environments.

  • Experience with finished goods suppliers or external manufacturing partners.

  • Lean/Six Sigma or continuous improvement background.

  • ASQ Certification (e.g., CQE, CQA, CSSGB) or equivalent.

Travel Percentage: 30%

Top Skills

Fda
Gmp
Iso 13485
Lean
Regulatory Standards
Six Sigma
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

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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