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Senior Quality Manager

Req ID:  2573

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

Site Quality Leader providing oversight, training and mentoring to the organization for quality systems, new product development, sustaining engineering, risk management, receiving inspection, production & process controls, complaint handling, supplier controls and end to end product quality.

Job Duties

* Mentors and leads the OVT Quality staff supporting new product development and sustaining engineering projects.

 

* Provides coaching and mentoring in Quality Systems– executing on robust and timely Quality Plans, CAPA’s, NC’s, Complaint Investigations, AE reporting, trending and signal detection, product issue escalations and a closed-looped Post Market Surveillance process.

 

* Site leader and champion for Olympus Quality Systems integration activities.

 

* Acts as the site Quality Management Representative - supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) as a host, front room point of contact and subject matter expert to demonstrate compliance to regulatory requirements and the OVT Quality System.

 

* Executes periodic Quality System Management reviews with OVT leadership.

 

* Budget responsibility for the local Quality team.

 

* Other Quality Assurance responsibilities 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 3 years of people-management experience.

 

* Hands-on Medical Device quality systems experience also required.

 

* High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required.

 

* Superior writing, composition, English grammar skills a must.

 

Other Considerations (travel/hours availability, etc.): 10-15% domestic and international 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.

 

* Provide quality direction to product development teams to achieve successful product introductions.

 

* Strong working knowledge of FDA QSR’s, MDSAP, ISO 13485, EUMDR, Quality Systems, Design Controls, Production and Process Controls, Complaint handling, trending, signal detection and post market surveillance.

 

* Skilled as a quality systems site management representative, prepping, hosting, leading and managing internal and external audits and CA responses.

 

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

 

* Visio skills desirable. 

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: Engineer, CAPA, Quality Manager, Manager, Quality, Engineering, Management

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