Address
Form of workWorking Location: Nationwide
Workplace Flexibility: Field
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Executive Director, Complaint Management is responsible for establishing and maintaining a complaint handling system which is compliant to US FDA regulations for complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803.3), EU MDR & MIR reporting, including all applicable in region.
The Executive Director, Market Quality shall have direct leadership, accountability and oversight of a Post Market Surveillance system for assessing and reporting to regulatory authorities for all data sources on Olympus products: adverse events (AEs), complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, compliance related communications from regulatory agencies and changes to relevant domestic and international standards and/or regulations for all Olympus products marketed in the Americas Region.
Job Duties
Job Requirements
Required:
Why join Olympus?
Here, people matter-our health, our happiness, and our lives.
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $156,256.00 - $234,384.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
About us:
Our 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 costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let's realize your potential, together.
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.
Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Field
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Executive Director, Complaint Management is responsible for establishing and maintaining a complaint handling system which is compliant to US FDA regulations for complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803.3), EU MDR & MIR reporting, including all applicable in region.
The Executive Director, Market Quality shall have direct leadership, accountability and oversight of a Post Market Surveillance system for assessing and reporting to regulatory authorities for all data sources on Olympus products: adverse events (AEs), complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, compliance related communications from regulatory agencies and changes to relevant domestic and international standards and/or regulations for all Olympus products marketed in the Americas Region.
Job Duties
- Responsible and accountable for global MIR Reporting. Including management and execution of global MIR procedures, local work instructions, practices and compliance of complaint and reporting performance, working in a global cross functional team.
- Responsible for cross functional teams (Medical Safety, Field Safety, Manufacturing, and R&D) that evaluate product risk and potential safety issues. The teams will assess deaths, serious injuries, and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable.
- The incumbent will hire, develop and organize a department of engineers, technicians, medical professionals, including managers, such that the team meets all requirements in an efficient, process, results oriented manner.
- The Executive Director will work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations is performance and documented in HHEs and safety evaluations of products.
- Responsible for working in partnership with Design Quality Assurance in resolving customer issues and developing continuous process improvement initiatives. Work with Olympus management and Design QA to ensure field performance and safety issues are properly addressed for new product requirements and/or risk management files. This individual will develop and implement programs to review literature and internet for potential complaints and AE/MIRs.
- Serves as a Core leadership team member reporting directly to the VP, Global Complaints Management
Job Requirements
Required:
- Bachelor of Science in medical, engineering, or scientific discipline
- Minimum of 10 years management level experience in a global drug/device manufacturer with strong concentration in complaint handling and MIR reporting including experience with (USA) and EU Quality System Regulations (QSR).
- Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
- Demonstrated experience in developing and leading a top performing Quality team is required.
- Proficient understanding of medical device regulations both domestic and international with specific expertise in; Complaint Handling, Adverse Event Reporting, Field Actions/Recalls, Regulator Inspections, product performance trending, risk management, and Corrective and Preventive Actions (CAPA)Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
- Up to 50% travel (In Region / International), if not co-located with an Olympus manufacturing and/or service center.
Why join Olympus?
Here, people matter-our health, our happiness, and our lives.
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $156,256.00 - $234,384.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
About us:
Our 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 costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let's realize your potential, together.
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.
Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)
