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Senior Quality Systems Engineer - Remote

Req ID:  3581

Working Location: Missouri, St. Louis 

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 Sr. Quality Systems Engineer will develop, maintain and improve the Quality System for the St. Louis (OVT) location to ensure it is compliant with domestic and international standards.

Job Duties

The Sr. Quality Systems Engineer is responsible for:

 

* Reviewing QMS Changes.

 

* Complaint handling and product investigations of device returns.

 

* Support continuous improvement opportunities.

 

* Preparing and maintaining Quality Metrics

 

* Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices.

 

* Serves as a mentor for the Quality team, when necessary, to assist in developing Quality Systems skills.

 

* Support and maintain device production and distribution activities, including: Provide data collection, review, and analysis of processes supporting production and product quality; Communicate information effectively; Quality representative for Material Review Board (MRB) activities.

 

* Support and maintain the Corrective and Preventive Action Process, including: Assist in maintenance of CAPA database and coordination of CAPA meetings; Complete assigned CAPA actions; Conduct and document verification of implementation and effectiveness of corrective and/or preventive actions.


 

* Identify areas requiring corrective and preventive action, including those resulting from non-conforming product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation.

 

* Support and participate in inspection and test activities.

 

* Support Quality Management System including assisting in internal/external audits and creating/revising SOPs and work instructions.

Job Requirements

REQUIRED QUALIFICATIONS:

 

*  Bachelor's degree or equivalent in an engineering or life science discipline is preferred. Evidence of continued learning efforts a plus.

 

* Minimum of 5 years progressively responsible experience operating as a Quality representative in a highly regulated manufacturing environment or equivalent experience required.

 

* Minimum of 3 years working in an FDA regulated environment required.

 

* Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards.

 

* Experience with risk analysis and reliability engineering techniques.

 

* Some travel will be required (less than 5%).

 

* Some extended workdays may be required.

 

* Access, Visio, database and statistical analysis software experience optimal.

 

* Ensure compliance to standards, regulations and Company procedures.

 

* Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required.

 

PREFERRED QUALIFICATIONS:

 

* Identifying requirements, setting realistic scheduling and meeting deadlines.

 

* Ability to identify issues, determine root cause, and implement solutions.

 

* Other project and duties as assigned.

 

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 www.olympus-global.com.

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: Quality Engineer, Senior Quality Engineer, Manufacturing Engineer, Systems Engineer, Engineering, Quality

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