Job Title
Senior Quality Manager
Company Name
Olympus
Company website
Company Overview
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’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.
Categories
Job Duties
This position is responsible for ensuring that the OSTA Quality System at their site remains in conformance with FDA and ISO13485 requirements and for managing their Quality staff to achieve key quality and delivery performance metrics. This position will directly support the Service Center operations ensuring the quality of repair operations throughout the organization. This position will serve as a key contact with internal stakeholders and suppliers and drive continuous improvement at the site.
Job Duties
* Manage day to day operations of Quality department at the site.
* Maintain organizational structure and align resources to achieve company quality and delivery goals while improving quality wherever necessary.
* Maintain and/or enhance quality system activities to ensure conformance to regulatory requirements.
* Drive quality improvements in concert with the needs of internal partners and key stakeholders at the site and throughout the Olympus business.
* Analyze quality system data including non-conformance reports production test results and other data sources for the identification of negative quality trends.
* Disseminate analysis of quality data to facilitate product quality and/or process improvements and ensure effective Corrective and Preventive action activities where needed.
* Responsible for ensuring that all MPRG supplier files are kept current and in good order.
* Develop staff to achieve service excellence in Quality Assurance personnel and assist in training site personnel in matters relating to product quality procedures and standards.
* Manage project activities as needed to ensure organization objectives.
* Maintain a leadership role with other departments as part of Cross Functional Teams NPI / NRI and other areas concerning Quality Assurance.
* Perform all other essential duties as directed.
Job Duties
* Manage day to day operations of Quality department at the site.
* Maintain organizational structure and align resources to achieve company quality and delivery goals while improving quality wherever necessary.
* Maintain and/or enhance quality system activities to ensure conformance to regulatory requirements.
* Drive quality improvements in concert with the needs of internal partners and key stakeholders at the site and throughout the Olympus business.
* Analyze quality system data including non-conformance reports production test results and other data sources for the identification of negative quality trends.
* Disseminate analysis of quality data to facilitate product quality and/or process improvements and ensure effective Corrective and Preventive action activities where needed.
* Responsible for ensuring that all MPRG supplier files are kept current and in good order.
* Develop staff to achieve service excellence in Quality Assurance personnel and assist in training site personnel in matters relating to product quality procedures and standards.
* Manage project activities as needed to ensure organization objectives.
* Maintain a leadership role with other departments as part of Cross Functional Teams NPI / NRI and other areas concerning Quality Assurance.
* Perform all other essential duties as directed.
Job Requirements
* Bachelor's degree in Quality Assurance Engineering or Production Management, or Bachelor's degree in another discipline with equivalent Quality Assurance knowledge required.
* Minimum of 3 years of experience in Quality Assurance.
* Minimum of 3 years of management experience.
* Minimum 3 years of experience in a strictly regulated environment, preferably in medical device.
* Minimum of 3 years of experience in Quality Assurance.
* Minimum of 3 years of management experience.
* Minimum 3 years of experience in a strictly regulated environment, preferably in medical device.
Skills/Experience Preferred
* CQE/CQA/CQM/RAC Certification preferred.
* Well-organized analytical logical practical.
* Strong written and verbal communication skills.
* Well-organized analytical logical practical.
* Strong written and verbal communication skills.
Benefits
Medical, Dental, Vision, 401k. PTO, 11 Annual Paid Holidays, etc
Hours
Full-time
Location
San Jose, CA
Other Application Requirements
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.
How to Apply
Resume