Senior Quality Engineer, Medical Devices

Position Summary

We are seeking a Senior Quality Engineer to support quality initiatives across product development, manufacturing, and post-market activities within a regulated medical device environment. This role partners cross-functionally with Engineering, Operations, Regulatory Affairs, and Supply Chain teams to ensure compliance with applicable quality system requirements while driving continuous improvement efforts.

Key Responsibilities

• Provide quality engineering support for medical device manufacturing and product development activities.
• Lead and support investigations related to nonconformances, customer complaints, deviations, and CAPAs.
• Participate in risk management activities, including development and maintenance of risk assessments and FMEAs.
• Support process validation, equipment qualification, and test method validation activities.
• Analyze quality metrics and process data to identify trends and improvement opportunities.
• Review and approve quality system documentation, including procedures, protocols, reports, and manufacturing records.
• Collaborate with cross-functional teams to address product and process quality issues.
• Support internal, customer, supplier, and regulatory audits.
• Ensure compliance with applicable quality standards, regulatory requirements, and company procedures.
• Drive continuous improvement initiatives to improve product quality, process performance, and operational efficiency.
• Provide guidance and mentorship to junior engineers and quality personnel.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Experience in a quality engineering role within the medical device industry.
• Working knowledge of FDA Quality System Regulations, ISO 13485, and other applicable regulatory requirements.
• Experience with quality systems, CAPA, root cause analysis, and risk management methodologies.
• Familiarity with validation activities, including process, equipment, and test method validation.
• Strong problem-solving, analytical, and interpersonal communication skills.
• Ability to work effectively in a cross-functional, fast-paced environment.

Preferred Qualifications

• Experience supporting both manufacturing and new product development activities.
• Knowledge of statistical analysis and quality tools.
• ASQ certifications or other relevant quality certifications.
• Experience working with suppliers and external manufacturing partners.

Key Competencies

• Quality Systems Compliance
• CAPA & Root Cause Analysis
• Risk Management
• Validation & Qualification
• Continuous Improvement
• Data Analysis & Problem Solving
• Cross-Functional Collaboration
• Audit Support & Regulatory Compliance
• Technical Leadership and Mentorship