Share this Job
Apply now »

Principal Quality Engineer

Req ID:  2973

Are you looking for a company that cares about people’s lives and health, including yours?

 

Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Job Description

The Principal Quality Engineer supports the development and manufacture of Olympus Veran Technologies (OVT) products during all phases of design, development, production, and distribution.

Job Duties

The Principal Quality Engineer is responsible for:

* Acting as the Quality Representative on Product Development project teams.


* Working cross-functionally to generate and maintain product Risk Management file(s).


* Reviewing QMS and product Design Changes.


* Defining Inspection and test methods and systems.


* 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 Engineering team to assist in developing Quality.

 

* Support design and development projects.

 

* Support and maintain device production and distribution activities, addressing quality issues and resolution using the current quality techniques and principles.   

 

* Participates in the CAPA process as required as an assignee or project team lead. 

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor's degree or equivalent in an engineering or life science discipline. 

 

* Minimum of 12 years of progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required.

 

* Severn or more years working in an FDA regulated environment optimal (Minimum of 5 years required).

 

* Some travel will be required (less than 5%); Some extended workdays may be required.

 

PREFERRED QUALIFICATIONS

* Leadership Experience: proven ability to lead and mange cross-functional teams, effectively communicate with all levels of management and drive effective change.

 

* 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.


* Identifying requirements, setting realistic scheduling, and meeting deadlines.  


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


* Ensure compliance to standards, regulations, and Company procedures.


* Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.


* Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred.  Access, Visio, database, and statistical analysis software experience optimal. 


* A natural at fostering collaborative relationships across all lines of the Company.

 

* This position is eligible for a sign-on bonus.

 

* Relocation benefits may be available for this position.

Veran® has been empowering earlier cancer diagnosis since 2005. Our mission is to save lives by helping doctors diagnose cancer earlier and provide precision guidance to deliver potentially lifesaving therapy. Olympus Veran Technologies is a leading provider of advanced medical devices specializes in interventional pulmonology.

 

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.

 

We also embrace diversity and inclusion. 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.

 

For more information, visit medical.olympusamerica.com.

 

True To You. True To Society. True To LIFE.


Nearest Major Market: St Louis

Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, CAPA, Engineering, Quality, Management

Apply now »