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Principal Quality Engineer

Req ID:  2874

Working Location: MINNESOTA, BROOKLYN PARK 

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

Develop maintain and support the company Quality System regulatory requirements and business strategy.Continuously improve Quality performance related to New Product Development procurement manufacturingand metrics related to the strength of the site Quality System... Leads complex projects. Mentors lessexperienced engineers within and across OSTA sites in best practices for the use of Quality tools and methods.Expected to serve as a backup to the Management Representative for the location.

Job Duties

* Leads and participates in Cross-functional teams to support new product development procurementmanufacturing representing Quality Engineering discipline.


* Leads or participates in the development of process and procedure/development changes.


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


* Develops new approaches to solve problems identified as part of the team.


* Assists others to lead and develop novel approaches within the 5E teams.


* Leads the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Qualitypolicies and procedures for the sites.


* Trains location personnel on all aspects of the Quality System and regulatory standards.


* Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills andcapabilities.


* Applies the requirements of the Quality System to processes products or services for the location.


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


* Develops and maintains the validation and verification strategy for new and existing products andprocesses. Leads the development and maintenance of Master Validation Plans.


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


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


* Authors, collaborates and approves Quality System documentation including change orders DHF DMR DHRlabels and labelling etc.


* Conducts internal vendor and process audits to schedule.


* Interfaces with suppliers to resolve Quality issues.


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


* All other essential related duties as required.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelors degree in Engineering discipline or equivalent. Masters Degree preferred.

 

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

 

* Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93/42 ISO13485-2003 and the ability to educate others on related subject matter.

 

PREFERRED QUALIFICATIONS


Viewed as an expert in the quality field.

 

* Leadership experience); proven ability to lead and manage cross-functional teams effectively communicate with all levels of management and drive effective change.

 

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

 

* Excellent verbal and written communication skills demonstrated by ability to generate technical reports andability 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 limitedstandardization and/or guidance exists.

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) || Minnesota (US-MN) || Brooklyn Park || 


Nearest Major Market: Minneapolis

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

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