Senior Staff Quality Engineer - Medical Devices

Regulatory Jobs; Arlington (TN); On-site; USD 103,000 - 171,000; Full time

Benefits offered by this job

Travel 10%

Job summary

Stryker in Arlington, TN is seeking a Senior Staff Quality Engineer to provide quality leadership across manufacturing operations. You will own investigations, CAPAs, MRB dispositions, and work with cross-functional teams to ensure compliance with FDA, ISO 13485, and GMP.

The role emphasizes data-driven decision making, risk management, and continuous improvement across facilities, with travel as needed. The position requires a strong background in quality engineering, regulatory affairs, and

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 7+ years in Quality Engineering, Quality Assurance, or Regulatory Affairs in a regulated industry.
• Strong understanding of ISO 13485, GMP and quality system requirements.
• Expertise in CAPA, Risk Management, RCA, Audits, Validation, and statistics.
• Experience with risk-based methodologies and statistical techniques.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication across all organization levels and cross-functional influence.
• Willingness to travel and manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead quality oversight for manufacturing processes and product quality.
• Own investigations, NCs, CAPAs, and root cause analysis.
• Collaborate with Operations, Engineering, and Supply Chain on quality and regulatory alignment.
• Lead internal and supplier audits and support regulatory interactions.
• Manage MRB dispositions, product holds, and risk mitigation activities.
• Provide SME input on risk management, CAPA, change management, validation, and statistics.
• Drive quality-related changes and risk assessments through data-driven decisions.
• Analyze quality metrics and drive continuous improvement.
• Support validation strategies and manufacturing transfers across facilities.
• Coach and mentor quality teams and represent Quality in reviews.

Skills

Quality leadership

CAPA ownership

Risk management

Data-driven decision making

Statistical methods

Lean Six Sigma

Process improvement

Audits

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in engineering or related field

Job description

Stryker in Arlington, TN is seeking a Senior Staff Quality Engineer to provide quality leadership across manufacturing operations. You will own investigations, CAPAs, MRB dispositions, and work with cross-functional teams to ensure compliance with FDA, ISO 13485, and GMP.

The role emphasizes data-driven decision making, risk management, and continuous improvement across facilities, with travel as needed. The position requires a strong background in quality engineering, regulatory affairs, and