Senior Quality Engineer

Responsibilities

• Provide quality engineering leadership and support for manufacturing, assembly, testing, packaging, and labeling operations, ensuring product quality and patient/user safety
• Ensure ongoing compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable regulatory and quality system requirements
• Serve as the Quality representative on operations and sustaining teams, partnering cross-functionally to balance compliance, risk, and business needs
• Lead document change requests and impact assessments to ensure changes maintain product safety, performance, and regulatory compliance
• Lead and support nonconformance investigations, root cause analysis, disposition decisions, and CAPA activities through effective closure and verification of effectiveness
• Apply structured problem-solving and statistical methods (e.g., 5 Whys, Fishbone, fault tree analysis, SPC) to drive data-based decisions and continuous improvement
• Own and maintain risk management and DMR documentation for commercial products, including periodic review of complaints, nonconformance trends, and post-market signals
• Review and approve process and test method validations, manage quality metrics, and oversee incoming material quality and acceptance activities

Qualifications

• 5+ years of experience as a Quality Engineer within the medical device industry
• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
• Preferred: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Belt

Knowledge & Skills

• Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971
• Demonstrated skills in statistical analysis
• Strong analytical and problem-solving skills
• Ability to work in a fast-paced, dynamic, and growth environment
• Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead or conduct teams and meetings
• Proven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectively
• Strong attention to detail
• Ability to educate cross-functional peers, stakeholders, suppliers and management on quality requirements
• Experienced with participation in audits