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Senior Quality Engineer, Process and System Governance

Req ID:  3290

Working Location: TENNESSEE, BARTLETT; Massachusetts, Boston 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
Let’s inspire healthier lives, together.

Job Description

Support the alignment of the global complaint handling process across Olympus globally with focus on the business process, system tools and master data that supports the efficient and accurate handling of product complaints in all markets.  This position will directly lead and/or support continuous improvement and sustaining efforts for the global processes and systems to assure compliance, harmonization, and efficiency.

Job Duties

* Provides executional and where appropriate, strategic guidance to elements for the global complaint handling processes and systems to establish and implement best practices in accordance with US and International requirements.


* Identifies and drives continuous improvement activities within the global complaint handling processes and systems through partnership with key functional groups and driving accountability through execution.


* Identifies areas of focus through data driven trending and brings solutions to management.  This responsibility includes liaising with internal and external parties on matters relating to the organization’s complaint handling processes and systems and the continued development in accordance with changes in Regulatory Agency requirements and Business needs.


* Report on the performance of the complaint handling processes and systems to Company management, as directed, for review and as a basis for improvement.


* Serve as global complaint Subject Matter Expert and Advisor including interacting with global regulatory agencies (e.g., FDA) in audit settings to effectively describe/defend Olympus complaint procedures and systems


* Responsible for coordination and oversight of external consulting resources to drive key continuous improvement projects for the global complaint system


* Oversee compliance, continuous improvement, change, and implementation of the Global Risk Summary Application (RSA)


* Ensures, through system, procedural and governance improvements that the complaint handling processes and systems are standardized throughout the business. Ensures that they are implemented consistently, correctly and measured through practical metrics.


* Ensures timely action and or escalation into the quality management system in accordance to and commensurate with the risk of the trends identified.


* All Other Essential Duties as directed.

Job Requirements


Bachelor’s Degree or equivalent in a technical or science-related field is required.


* Minimum of 4 years experience working in manufacturing, finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.


* Minimum of 3 years of related experience analyzing, clarifying and translating business requirements into functional and technical specification.


Other Considerations (travel/hours availability, etc.):Approximately 25% travel, including globally. Flexible working hours across multiple time zones, due to the Global nature of this role.



* Master’s Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline.


Six Sigma Green Belt and Lean certifications, Six Sigma Black Belt preferred.


* Proficient with statistics, sampling strategies, quality systems trending, process capability, including statistical software tools.


* Knowledge of Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.


* Ability to influence across multiple sites.


* Ability to consistently deliver on required activities and meet assigned deadlines.


* Demonstrated ability to manage and complete multiple projects and assigned objectives


* Prior experience leading cross-functional teams.


* Excellent verbal and written communication skills, including public speaking and facilitation.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit

Olympus…True To You. True To Society. True To LIFE.


It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || 

Nearest Major Market: Worcester

Job Segment: Process Engineer, Quality Engineer, Engineer, Manufacturing Engineer, Engineering, Quality

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