Olympus America Inc. Engineer, Quality Assurance - OCI in United States
Utilize and develop 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.
Participate 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 internal reviews of all service areas and preparing quantitative analysis (quality system data, 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 identify solutions to address areas of concerns.
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.
Perform all other essential duties as directed.
Exhibits 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.
Richmond Hill, CA - Under the Quality Assurance Manager, the Quality Assurance Engineer is responsible for supporting the development of service standards and audits, continuous quality improvement, and supporting 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 supports Quality Assurance System to ensure compliance with best services practice. The incumbent will support the OCI Service Center operations, ensuring the quality of repair operations throughout the organization. He/She champions, develops and promotes quality activities to meet regulatory and quality requirements while supporting business goals and improving customer satisfaction.
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)
Associate's or Bachelor’s Degree in Quality Assurance, Engineering, or Production Management, or in another discipline or equivalent Quality Assurance knowledge is required.
Minimum of 1 year of experience in Quality Assurance is preferred.
Minimum of 3 years of medical device experience is preferred.
CQE/CQA/CQM/RAC Certification is preferred.
Must be well-organized, analytical, logical, practical.
Strong written and verbal communication skills are essential.
Quality System CAN/CSA ISO13485:03 is preferred.
Strong personnel management skills, with a demonstrated track record of growing personnel is desired.
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/
Canada, Ontario, Richmond Hill
Quality Assurance Engineer - OCI
Reg Affairs/Quality Assurance
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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.