Principal Engineer, Quality Systems

Working Location: MASSACHUSETTS, WESTBOROUGH 

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

To develop, maintain and continuously improve the Quality System across the Americas by specifically supporting the Westborough site in by driving industry best practices, procedural harmonization and seamless quality system integration through development of robust Quality plans. Act as an ambassador of global Quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.

 

Job Duties

• Ensures that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and International requirements.
• Review and approve release of changes to QMS documentation.
• Coordinate with other functions and sites to ensure accurate, complete, and efficient change processing.
• Ensure implementation and execution of global corporate procedures into regional practices.
• Identify areas of focus through data-driven trending and bring solutions to management.
• Ability to synthesize quality signals, extract critical information to inform plans, and develop actions for addressing and improving the quality system.
• Support internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner.
• Act as Audit Finding coordinator.
• Support CAPA process, monitor progress of records, help facilitate CAPA board meetings, and support CAPA owners to drive closure of corrective action plans.
• Show strong ability to influence without direct authority across functional groups, regions, and leadership.
• Provide resident expertise in the application of Quality Sciences including statistics, data analysis, problem-solving, and the creation of system solutions for Quality System issues.
• Act as an expert resource in applicable standards and local QMS requirement knowledge for cross-functional teams.
• Report on the performance of the quality system to Company management, as directed, for review and as a basis for improvement of the quality systems.
• Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
• Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices.
• Perform all other essential duties as directed.

Job Qualifications

Required:

• BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
• Minimum of 6 years’ experience working in a highly regulated industry required.
• Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams.
• Proficient with DMAIC / Lean Six Sigma /Black Belt type tools to analyze, drive root cause, and solve problems.
• Proficient with statistics, sampling strategies, quality systems trending, process capability.
• Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSRs, ISO 13485, ISO 14971. 
• Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
• Strong track