Principal Quality Engineer, Complaint Management Compliance

Working Location: NATIONWIDE 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

The Principal Quality Engineer, Complaint Management Compliance is an experienced professional with wide-ranging experience and expertise in CAPA to ensure regulatory compliance and patient safety

Job Duties

• Lead and oversee the Complaints Global CAPAs, ensuring timely identification, investigation, and resolution of quality issues.
• Follow global CAPA procedures and guidelines in alignment with regulatory requirements. 
• Provide training to staff on CAPA processes, quality systems, and regulatory requirements.
• Serve as a subject matter expert on quality engineering practices and compliance.
• Conduct thorough investigations to determine root causes of quality issues and non-conformances.
• Utilize various problem-solving methodologies (e.g., Fishbone diagrams, 5 Whys, etc.) to facilitate effective analysis.
• Perform risk assessments related to identified CAPAs and develop mitigation plans.
• Collaborate with cross-functional teams to assess the impact of quality issues on product safety and effectiveness.
• Ensure proper documentation of CAPA activities, including investigation reports, corrective action plans, and effectiveness checks.
• Prepare and present CAPA reports to management and regulatory bodies as needed.
• Work closely with other departments, such as R&D, Manufacturing, and Regulatory Affairs, to ensure alignment on quality objectives.

Job Qualifications

Required:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.
• A minimum of 10 years of experience in quality engineering, quality assurance, or regulatory compliance within a relevant industry (e.g., medical devices, pharmaceuticals).
• A minimum of 5 years of experience in CAPA.
• Strong knowledge of quality management systems (QMS) and regulatory standards (e.g., ISO 13485, FDA regulations).
• Travel up to 20% of the time domestically or internationally, availability to take evening and early morning teleconferences.

 

Preferred:

• Analytical Skills: Strong ability to analyze data, identify trends, and perform root cause analysis using various methodologies.
• Problem-Solving: Proficient in developing and implementing corrective and preventive actions to address quality issues.
• Regulatory Knowledge: Familiarity with industry regulations and standards (e.g., FDA, ISO, GMP) to ensure compliance in all CAPA activities.
• Project Management: Skills in managing multiple CAPA projects, including planning, execution, and follow-up, to ensure timely resolution of issues.
• Communication: Excellent verbal and written communication skills for effec