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Senior Quality Manager

Job Description 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. We're currently looking for a Senior Quality Manager to join us in our Norwalk, OH office.   Let's inspire healthier lives, together. The Senior Quality Manager manages the execution of the Quality System to ensure compliance with regulatory requirements and the business strategy of the company. The incumbent serves as the Quality leader to support new product development, procurement, manufacturing, returns and servicing of products produced at the location. He/She will serve as the Management Representative for location. The incumbent supports OSTA as a subject matter expert and can serve as a delegate for the Executive Director of OPS Quality. Job Duties: As a the Senior Manager of Norwalk Quality working on the Norwalk team, you will be empowered and inspired to do your best work.    Manage Quality staff to support new product development, procurement, manufacturing and servicing processes.  Ensure location personnel are trained to meet their respective responsibilities and duties.  Mentor and lead quality engineers.  Serve as a subject matter expert in Quality Engineering for OSTA.  Mentor the Quality organization in developing Quality Engineering skills. Maintain responsibility to ensure requirements of the Quality System are applied and adhered to for the location, products and services produced.  Support validation and verification strategy for new and existing products and processes. Serve as CAPA board member and is responsible to ensure an effective process.  Manage the product complaint system to ensure timely customer response and corrections.  Monitor performance metrics and acts upon trends (positive or negative).  Ensure proper disposition of non-conformances. Ensure the appropriate management of all QS documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.  Ensure internal, vendor, and process audits are conducted to schedule with corrections made for any deficiencies observed.  Develop, negotiate and implement quality agreements between company entities.  Supplier Review Board member and ensures that suppliers are qualified to supply components to meets the design requirements. Maintain responsibility for control of condition for sterile manufacture, integrity of sterile packaging, approval of goods purchased sterile, sterilization contractors and sterilization cycle validation. (As applicable to the location).  Budget responsibility for the Quality organization for the location and monitor performance to budget. Lead Quality initiatives/projects that affect all OSTA sites.  Serve as the Management Representative for the location.  Manage facility audits by outside agencies (i.e., FDA, ISO) to demonstrate compliance to regulatory requirements and Quality System.  Ensure audits conducted that result in deficiencies are corrected per policy.  Ensure semi-annual Management Review is conducted per policy.  Develop and drive measurable Quality improvements relating to products, processes and services. Perform all other essential related duties as required.   Job Requirements: REQUIRED QUALIFICATIONS: Bachelor's Degree or equivalent is required. Minimum of 7 years of related experience and/or training; or equivalent combination of education and experience. Preferably in medical device industry.   Requires background and familiarity with U.S. FDA QSR, requirements including MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements Travel up to 25% of the time.  PREFERRED QUALIFICATIONS: Japanese Pharmaceutical Affairs Law (JPAL) certification is preferred. ASQ certifications in one or more of the following areas is preferred but not required: ASQ Certified Manager of Quality/Organizational Excellence (CMQ/QE), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE).  Working knowledge of problem solving skills - good statistical and analytical skills.  Proven Management and leadership skills; ability to lead and manage cross-functional teams.  Proficient in the use of Information Technology. 4186BR
Salary Range: NA
Minimum Qualification
8 - 10 years

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