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Senior Quality Systems Engineer-CAPA

Req ID:  5811

Working Location: Missouri, St. Louis; Missouri, Kansas City 


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

The Senior Quality Engineer, CAPA is responsible for CAPA system ownership, execution, and support for Veran Quality Assurance as required, in close collaboration with groups within Veran and OSTA.

This position may lead a team of SMEs in the execution of CAPA activities to ensure that actions are executed in compliance with all applicable global regulations and laws. This position may also be responsible for the creation and/or revision of local/ global processes to support the VMT organization to meet all applicable regulations and laws, driving corrective and preventive actions. This position requires a thorough understanding of FDA regulatory requirement for complaint handling and MDR reporting. Provides supports in the continuous improvement effort of the VMT quality system for processing CAPAs to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Proposes solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Performs timely closure of CAPA issues in accordance with established procedures. Lead CAPA, Nonconformance and other QMS projects to improve department processes, procedures, and responsibilities.

Job Duties

* Lead corrective and preventative action (CAPA) activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving systemic non-conformance.


* Guide and support colleagues in the CAPA investigation process, assisting to remove roadblocks to timely investigation completion.


* Communicate directly with internal VMT colleagues and Olympus field personal as necessary to support CAPA investigation and resolve issues. Use investigation findings to generate written communications. Ensure consistent messaging to all concerned on similar concerns, coordinating with internal stakeholders to review content of communication.


* Review CAPA records for accuracy and completeness. Perform CAPA issue closure in a timely manner. Identify, and assist in removing, roadblocks to timely file closure.


* Provide technical support to Operations technicians, administration staff and production shop floor staff relative to technical investigations. Serve as a technical trainer to the VMT Quality team members as needed.


* Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


* Work directly with manufacturing sites, subcontractors, and OEMs to facilitate corrective and/or preventive actions related to quality problems identified through CAPA investigation and/or other sources of quality data. Review and approve manufacturer’s investigations for accuracy and relevance to reported complaints.


* Develop, manage, and run reports in database systems for the purpose of trend monitoring and/or CAPA investigation. Lead and facilitate responsible parties to resolve issues. Reviews associated QMS records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.


* Assist local management team in reviewing process implementation and provide recommendation to resolve processing challenges, increase productivity and improve workflow.


* Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in the field of complaint processing on topics relating to physical device inspection, complaint investigation and data trending.


* Perform other related duties as assigned.

Job Requirements



* A four-year degree in a technical discipline (e.g., EE, ME, BME, Quality Assurance), or equivalent knowledge & experience.


* Minimum of 5 years’ experience dealing with regulatory or quality assurance issues in the medical industries. Specific experience in CAPA activities. Knowledge of Quality System Requirements (21 CFR 820 & 803), ISO 13485 and the MDD is required. EUMDR experience desirable.


*  Other Considerations (travel/hours availability, etc.):Available to travel to customer sites for product evaluation, ~10%.  Available to travel to the manufacturing sites for product training, ~5%. This is primarily an on-site position; a limited hybrid work schedule is possible.




* Previous experience working with different CAPA handling systems, e.g. Agile, Etc.


* Effective written and verbal communication skills.


* Strong analytical, organizational, communication and interpersonal skills are required.


* Computer literate with experience in Microsoft Office Suite.


* Previous experience working with complaints, CAPAs, NCRs, and other quality management system functions.

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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.


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) || Missouri (US-MO) || St. Louis || 

Nearest Major Market: St Louis

Job Segment: Senior Quality Engineer, Quality Assurance, QA, Systems Engineer, CAPA, Engineering, Quality, Technology, Management

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