Olympus America Inc. Mgr., Quality Assurance in United States
Develop and use statistical tools and procedures for volume and service monitoring, including trend analysis and forecasting.
Analyze, summarize and present service data in formats that fulfill a variety of internal and external requirements.
Maintain organizational structure and align resources to achieve OCI quality and delivery goals while participating in the development of plans to ensure improvement in the quality of service.
Work with Regulatory Department (RA/QA) to maintain and enhance quality system activities to ensure conformance to regulatory requirements.
Perform various internal audits and reviews as assigned; identifying quality assurance concerns and providing recommendations for addressing those concerns.
Conduct weekly internal reviews of all service areas and preparing quantitative analysis (quality system data, non-conformance reports, production test results, and other data sources for the identification of negative quality trends) and disseminate reports to the Director of Service & repair, in a timely manner.
Ensure a quality assurance mindset is reflected throughout the organization through quality control mechanisms.
Monitor, analyze and report problem areas and identifying strategies to address areas of concern.
Coordinate Change Notices (CNs), Non Conformance Reports (NCR), Corrective and Preventative Action (CAPAs), and Corrective Action Reports (CARs) in a timely manner, to close and/or achieve acceptable levels of compliance.
Investigate and report weekly on discrepant material notices (DMNs).
In collaboration with Supervisors and Managers, conduct random quality assurance testing of services to clients to determine quality of service and developing corrective action plans if services are not meeting expected outcomes.
Work with external organizations and quality assurance specialists to ensure best practice quality assurance functions and methods within its quality assurance program.
Conduct monthly reviews of all serious occurrences and compiling a quarterly report for the Directors including recommendations for quality improvement.
Maintain responsibility for ensuring Quality Assurance committee is functioning properly and at its full capacity.
Exhibit all corporate and divisional expectations of people leaders to include, but not be limited to developing employees, managing employee performance/engagement, promoting continuous improvement, managing department business/communications, driving organization alignment, selecting/retaining talent, and consistently modeling excellence, integrity, and accountability.
Perform all other essential duties as directed.
Richmond Hill, ON - Under the Direction of Service & Repair, the Quality Assurance Manager is responsible for managing and supporting the development of service standards and audits, continuous quality improvement, and developing plans to meet quality assurance objectives and key performance indicators. The incumbent provides reports on quality assurance and program evaluation as well as statistical analysis for the organization. He/She identifies designs and implements Quality Assurance System to ensure compliance with best services practice. The incumbent will directly support the OCI Service Center operations, ensuring the quality of repair operations throughout the organization. He/She champions and promotes quality activities in Service Department to meet regulatory and quality requirements while supporting business goals and improving customer satisfaction. The incumbent will be accountable for developing and executing solutions relating to quality and ensuring the Quality Management System is implemented and maintained effectively in Service.
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!
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor’s degree in Quality Assurance, Engineering, or Production Management, or equivalent is required.
Minimum of 3 years experience in Quality Assurance is required.
Minimum 3 years of medical device experience is preferred.
Minimum of 2 years management experience is preferred.
CQE/CQA/CQM/RAC Certification is preferred.
Must be well-organized, analytical, logical, practical.
Strong written and verbal communication skills are necessary.
Quality System CAN/CSA ISO13485:03 skills are preferred.
Strong personnel management skills, with a demonstrated track record of growing personnel are essential.
Hepatitis B vaccination is recommended for employees who are at risk for exposure to blood or other bodily fluids on the job. Service responsibilities include the handling of products and equipment that may have potentially come into contact with blood or bodily fluids. OCI requires that all employees working in areas that may be exposed to these risk, either provide proof of the Twinrix (Hepatitis A and B) vaccination or sign a waiver accepting the possible risk of exposure from not being vaccinated. If you have severe allergies or ever had a severe allergic reaction to a vaccine, please seek medical advice before taking this vaccine.
Olympus Canada with headquarters in Ontario, is a precision technology leader, creating innovative opto-digital solutions in health care, life science and consumer electronics products throughout Canada. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include: gastrointestinal endoscopes, accessories, and minimally invasive surgical products; advanced clinical and research microscopes; digital cameras and voice recorders. Olympus Canada
Olympus Canada at http://www.olympuscanada.com/
- QA Technicians and Inspectors
Canada, Ontario, Richmond Hill
Quality Assurance Manager
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Olympus is an Equal Opportunity Employer, and our policies 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.