Senior Quality Engineer

Stryker Group; Salt Lake City (UT); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior Quality Engineer to join its Global Quality Operations team. This role requires a dedicated professional passionate about quality excellence and lean methodologies. You will operate independently within the Quality Operations team, ensuring compliance and leading manufacturing improvements. Ideal candidates possess a Bachelor's degree in a relevant discipline and have solid experience in quality assurance practices.

Qualifications

• Minimum of 2+ years of experience in quality, manufacturing, or new product development.
• Experience with cGMP and GDP standards for regulatory compliance.

Responsibilities

• Ensure compliance and excellence in quality-related activities across products and processes.
• Collaborate with teams for quality performance improvements.
• Manage nonconformances and corrective action processes.

Skills

Quality Management

Lean Methodologies

Risk Management

Statistical Analysis

Education

Bachelor’s Degree in a Science or Engineering related discipline

Job description

Stryker is hiring a Senior Quality Engineer for our Global Quality Operations where you'll play a key role in driving quality excellence and delivering impactful results. We’re looking for a passionate advocate of quality and lean methodologies—someone who thrives in a fast-paced environment, takes initiative, and communicates effectively across all levels of the organization. If you're a self-directed Quality professional committed to ensuring superior product quality for patients and customers, we want to hear from you.

What you will do:

• Operate independently within the Quality Operations team, ensuring compliance and excellence in quality-related activities across products and processes.

• Collaborate with cross-functional teams to drive quality performance, lead manufacturing process improvements, and support new product introductions.

• Manages and provides oversight, approval, and mentorship in nonconformances and corrective action preventative actions (NC/CAPA) processes, root cause analysis, and problem-solving initiatives.

• Review and approve change management, validation, and qualification activities for processes and equipment.

• Monitor and analyze quality KPIs, identify trends, and implement corrective actions to maintain process integrity.

• Apply advanced risk management and Human Factors principles to proactively identify and mitigate quality risks.

• Optimize inspection methods, support First Article Inspections, and apply statistical tools to enhance product quality.

• Represent Quality in internal and external audits, lead quality efforts in manufacturing transfers, and manage product holds and potential escapes.

• Support the execution and analysis of manufacturing complaints and product field actions.

What you need:

Required Qualifications:

• Bachelor’s Degree in a Science or Engineering related discipline.

• Minimum of 2+ years of experience as an Engineer working within quality, manufacturing, or new product development.

• Experience in adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory standards.

Preferred Qualifications:

• Proficient in medical device manufacturing processes with a strong understanding of ISO 13485 and industry standards.

• Certification in one or more of the following: Certified Quality Engineer (CQE), Lead Auditor and/or Lean Six Sigma.