Principal Quality Engineer, Complaint Process Excellence

Working Location: PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

 

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.

 

 

Job Description

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

Job Duties

• Establish and uphold a unified framework for process governance that ensures compliance, enhances transparency, and fosters collaboration across all regions.
• Ensure that process changes are logical and align cohesively with the broader end-to-end process.
• Lead continuous improvement efforts to optimize the complaint management process, ensuring effectiveness, efficiency, and regulatory compliance.
• Design and implement best practices for complaint handling, 
• Develop, review, and maintain standard operating procedures (SOPs) for complaint handling processes.
• Lead 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 quality systems, and regulatory requirements.
• Serve as a subject matter expert on quality engineering practices and compliance.
• Collaborate with cross-functional teams to assess the impact of quality issues on product safety and effectiveness.
• 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).
• 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 Process and CAPA activities.
• Communication: Excellent verbal and written communication skills for effectively conveying information to cross-functional teams and documenting findings.
• Collaboration: Ability to work effectively with diverse teams, fostering collaboration among engineering, production, quality assurance, and regulatory affairs.
• Attention to Detail: A keen eye for detail to ensure thorough investigations and accurate documentation.
• Technical Knowledge: Understanding of the product lifecycle and engineering principles relevant to the industry.
• Continuous Improvement Mindset: Commitment to identifying opportunities for process enhancements and promoting a proactive approach to quality management.
• Travel up to 20% of the time domestically or internationally,