Senior Quality Engineer

Senior Quality Engineer

Drive quality excellence in a regulated manufacturing environment.

As a Senior Quality Engineer, you’ll play a critical role in ensuring products meet the highest quality, regulatory, and customer standards. You’ll lead quality initiatives across manufacturing and supplier operations, apply data-driven problem-solving methods, and collaborate cross-functionally to drive continuous improvement in a highly regulated industry.

What You’ll Do

• Define and maintain detailed inspection and testing requirements to ensure product quality
• Ensure products consistently meet internal quality standards and applicable industry regulations
• Develop and refine inspection and testing methods to assess and improve product quality
• Lead Corrective and Preventive Action (CAPA) investigations and process improvement initiatives
• Develop, maintain, and monitor measurement systems to ensure compliance with ISO and FDA regulations
• Partner with suppliers to investigate root causes and implement corrective actions for raw material or component issues
• Monitor and evaluate supplier processes to ensure compliance with purchase orders, specifications, and engineering requirements
• Deploy variation management tools at suppliers to proactively mitigate quality and supply risk
• Conduct supplier audits and establish clear supplier quality requirements
• Analyze and report supplier quality performance trends, escalating risks and opportunities to leadership
• Design and implement methods for process control, testing, inspection, and continuous improvement
• Create and maintain process flow diagrams, workplace layouts, FMEAs, and standardized work instructions
• Support additional quality and engineering initiatives as needed

What You’ll Need to Succeed

Education & Experience

• Bachelor’s degree in Engineering or a related technical field (Master’s degree preferred)
• 3–7 years of experience in a high-volume, regulated manufacturing environment (medical device experience strongly preferred)

Technical Expertise

• Hands-on experience with Six Sigma, Lean manufacturing, and quality management tools
• Strong understanding of statistics and statistical process control (SPC)
• In-depth knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820
• Solid understanding of medical device regulations and international quality standards
• Experience with complaint handling systems and quality data analysis tools
• Proficiency in Microsoft Excel and Access databases
• Ability to read and interpret engineering drawings, specifications, and technical documentation
• Working experience with CAD tools such as SolidWorks is a plus
• ASQ Lead Auditor certification or equivalent auditing training preferred

Professional Skills

• Strong analytical and problem-solving capabilities
• Excellent written, verbal, and interpersonal communication skills
• Ability to work independently, take initiative, and drive projects to completion
• Collaborative mindset with the ability to influence cross-functional teams
• Comfortable balancing hands-on execution with strategic quality initiatives

If you meet the above qualifications and would like to apply for this position, you may email your up-to-date, professional CV/resume to Tim Dameron @ timothy.dameron@adeccona.com.

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