Quality Engineer

Responsibilities

• Develop and implement quality systems to ensure medical products meet or exceed customer expectations and regulatory requirements (FDA, Health Canada, EU MDR).
• Provide quality engineering support throughout the product lifecycle, including risk management, design/manufacturing changes, and CAPA investigations.
• Drive supplier quality improvement through engineering analysis, root cause analysis, and participation in supplier qualification.
• Conduct trend analysis and implement problem-solving methodologies to reduce internal and external defects.
• Validate key design inputs including usability, reliability, performance, and safety.
• Author validation, verification, and inspection assessments to support product release.
• Maintain knowledge of relevant standards such as ISO 14971 and IEC 60601 to ensure continuous compliance.

Requirements

• 3+ years of engineering experience, ideally within the medical device industry.
• Bachelor's degree in Engineering (typically Electrical or Mechanical).
• Strong working knowledge of medical device regulations including 21CFR820, MDD, and MDR.
• Proficiency with quality system standards such as ISO 14971 and IEC 60601.
• Experience with product verification, process validation, and test system development.
• Practical experience implementing statistical tools and techniques.

Preferred Qualifications

• Master's degree in Engineering or an MBA.
• ASQ Certification.
• Working knowledge of Lean and Six Sigma tools and concepts.

Benefits

• Medical, Dental, and Vision coverage.
• 401K Plan with company match.
• Generous time off and paid parental leave.
• Income protection and Work Life Assistance Program.
• Educational benefits and Worldwide Scholarship Program.

About the Company

Brasseler (a Henry Schein company) is a world-class healthcare organization providing high-quality, clinician-endorsed dental and medical instrumentation. With a reputation spanning over 40 years, we are dedicated to innovation, integrity, and helping health happen.