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Principal Quality Engineer

Req ID:  2459

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 Principal Quality Engineer develops, maintains, and supports the company Quality System regulatory requirements and business strategy.  They continuously improve Quality performance related to New Product Development procurement manufacturing and metrics related to the strength of the site Quality System. They lead complex projects. The sucessful candidate mentors less experienced engineers within and across ISM sites in best practices for the use of Quality tools and methods.

Job Duties

* Quality department representative on Cross Functional Teams providing quality input for new product development procurement manufacturing and servicing processes.

 

* Conducts supplier audits and interfaces with suppliers to resolve Quality issues.

 

* Leads or participates in the creation and change of processes and procedures.

 

* Mines data from various Olympus and Image Stream data sources and creates product reliability metrics and creates reports for management review.

 

* Provides expertise in the application of Quality Sciences including statistics, data analysis, problem solving, and the creation of system solutions.

 

* Develops new approaches to solve problems identified resulting from team interactions.

 

* Manage complex projects through completion by collaborating with various functions to ensure all project requirements are met.

 

* Mentor and advises the Quality team to assist in developing QualityEngineering skills and capabilities.

 

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

 

* Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.

 

* Creates product and process performance metrics and acts upon trends with minimal guidance.

 

* Authors collaborates and approves Quality System documentation including change orders DHFDMR DHR labels and labelling.

 

* Develops and drives measurable Quality improvements relating to products, processes, and services.

 

* Perform other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree in an Engineering discipline or equivalent.

 

* Minimum of 15 year's of related experience, preferably in the medical device industry related to process/quality engineering.

 

* Requires strong understanding of U.S. FDA QSR requirements. 

 

PREFERRED QUALIFICATIONS:

 

* Master's Degree is preferred.

 

* Leadership experience is preferred

 

* Proven ability to lead and manage cross- functional teams effectively and communicate with all levels of management and drive effective change.

 

* Good understanding of ISO 9001 MDD 93/42 ISO 13485.

 

* Strong Quality Science skills including demonstrated statistics application and problem solving.

 

* Excellent verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management.

 

* Proven Project Management skills with ability to manage cross functional team and produce results.

 

* Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.

 

* Must be able to perform necessary research to provide objective evidence in support of decisions.

 

* Ability to conduct root cause analysis and risk assessments.

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, Manufacturing Engineer, Engineer, CAPA, Engineering, Quality, Management

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