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Quality Vice President
Olympus
Brooklyn Park, MN, United States
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MBC Quality Vice President
About Us
Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Gyrus ACMI
Job Description
Brooklyn Park, MN - The purpose of the MBC Quality Vice President 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.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
At Olympus, we are True to You!
Job Duties:
• Serve on OSTA EXCOM as Senior QA representative.
• Lead OSTA level Management Reviews.
• Maintain responsibility for managing the department budget and business process.
• Maintain responsibilty for establishing and managing Quality Operations functions, including inspection, process validations/verifications, NCMR, and final release.
• Maintain responsibility for establishing and managing the External Quality Operation functions including receiving inspection, quality planning, Supplier Process Validation/Verifications, and Material Review Board.
• Maintain responsibility 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.
• Maintain responsibility for setting up and managing the Supplier Quality System, including supplier selection, supplier control, supplier change management, and supplier development and improvement projects.
• Maintain responsibility 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.
• Perform all other essential duties as required.
Job Requirements:
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
• Bachelor's degree is required, MBA is preferred.
• Minimum 10 years experience in Medical Device Industry is required.
• Minimum 5 years experience serving on organization leadership is required.
• Minimum 5 years experience in directly leading and developing people and teams is required.
• Minimum 5 years experience leading Quality, Manufacturing, or Product Development Skills is required.
• Expert understanding in at least one of the following is desired: Production and Process Control, Supplier Controls, Design Control, Risk Management Strong People.
• Must be a leader with experience raising the skill level of the organization.
• Must possess the ability to work with Business Partners in other Functions to achieve business results.
• Business principles working in a regulated environment is essential.
• Must focus on customer.
• Some travel will be required but no more than 25%.