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Vice President, MBC Quality

Req ID:  4021

Working Location: MASSACHUSETTS, WESTBOROUGH 

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 purpose of this position is to provide leadership and management to the Quality functions of product design product manufacture product procurement. In addition this role will serve as the point person from a Regulatory Compliance viewpoint for all MBC facilities that serve as the Legal Manufacturer of Olympus Surgical Technologies of the Americas (OSTA). This role will serve as a member of the OSTA Executive Committee Member and will be a part of the Project Approval Board.

Job Duties

* Serve on OSTA EXCOM as Senior QA representative.

 

* Lead OSTA level Management Reviews.

 

* Responsible for managing the department budget and business process.

 

* Responsible for establishing and managing Quality Operations functions including inspection process validations/verifications NCMR and final release.

 

* Responsible for establishing and managing the External Quality Operation functions including receiving inspection quality planning Supplier Process Validation/Verifications and Material Review Board.

 

* Responsible for establishing and managing the Product Quality (Design Quality) function including participation in Design Validation/Verification Risk Management and Product Lifecycle Management. Responsible for assuring the product -abilities (usability clean-ability manufacturability serviceability and reliability) are addressed during the Product Design Process.

 

* Responsible for setting up and managing the Supplier Quality System including supplier selection supplier control supplier change management and supplier development and improvement projects.

 

* Responsible for establishing and managing a Microbiology function that serves as SME on sterility science on single use product and clean- ability of reusable product.

 

* Assure all manufacturing sites are in a state of compliance.

 

* Develop the next generation of Quality thought leaders.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree required; MBA preferred.

 

* Minimum of 10 years experience in Medical Device Industry.

 

* Minimum of 5 years experience serving on organization leadership. 

 

* Minimum of 5 years experience in directly leading and developing people and teams.

 

* Minimum of 5 years Experience leading Quality Manufacturing or Product Development.

 

* Some Travel will be required but no more than 25%.

 

PREFERRED QUALIFICATIONS:

 

* Expert Understanding in at least One of the Following: Production and Process, Control Supplier, Controls Design, Control Risk Management.

 

* Strong People Leader with experience raising the skill level of the organization.

 

* Ability to work with Business Partners in other Functions to achieve business results.

 

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) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Executive, VP, Inspector, QA, Quality, Management

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