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Product Quality Manager

Req ID:  2749

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

Quality Leader providing strategy execution, oversight, training and mentoring to the organization for new product development, sustaining engineering, risk management and end to end product quality.

Directly responsible for the Product Quality Organization in Brooklyn Park, MN – including ProductQuality Engineering, and the Human Factors Engineering support.

Job Duties

* Executes vision and strategy for the Brooklyn Park owned product development process outputs, portfolio and pathologies.

 

* Mentors and leads the Brooklyn Park Product Quality Engineering staff supporting new product development and sustaining engineering projects.

 

* Mentors and leads the Human Factors/ Usability Team supporting new product development and sustaining engineering projects at the site.

 

* Champion and subject matter expert for customer and patient focused end to end Risk Management.

 

* Supports all aspects of the product lifecycle for products in scope, including sustaining activities, design change management, complaint investigations and ongoing risk management activities/post market surveillance.

 

* Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) and acts as a subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Quality System.

 

* Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions.

 

* Other Quality responsibilities and special projects as assigned by Management.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelor's degree or equivalent in engineering or life science discipline. Master's degree or other advanced degree strongly preferred.

 

* Minimum of 8 years of professional experience, or equivalent training, or equivalent training/education in quality or other engineering discipline.

 

* Minimum of 3 years working in medical device new product development and people leadership.

 

* Other Considerations (travel/hours availability, etc.): up to 15% domestic travel.

 

PREFERRED QUALIFICATIONS

 

* Proven track record in the global execution of New Product Development delivering on robust, customer and patient focused product quality.

 

*  Concept through Post-Launch for WW markets.

 

* Strong technical skills related to product quality including VOC translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.

 

* Ability to drive value and product differentiation through the Product Quality Team.

 

* Strong working knowledge of FDA QSR’s, MDSAP, ISO 13485, EUMDR, Design Controls, Human Factors, Risk Management practices.

 

* Strong working knowledge of technical problem-solving skills. Design or Process Black Belt is a plus.

 

* Strong collaboration and influencing skills and the ability to work across functions.

 

* Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.

 

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: Engineer, Manager, Inspector, Quality Manager, Quality, Engineering, Management

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