Olympus Corporation of the Americas
Complaints Director
Olympus Corporation of the Americas, Center Valley, Pennsylvania, United States,
Workplace Flexibility:
Field
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.
Job DescriptionThe Complaint Director is responsible for establishing and maintaining a complaint handling process inclusive of complaint investigations and system which is compliant to US FDA regulations for complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803.3), ISO 13485:2016 (EMEA), Canadian & Brazilian vigilance reporting. This position will be responsible for maintaining compliance to OCI & LATAM requirements.
The Complaint Director shall have direct leadership, accountability, and oversight of a Post Market Surveillance system responsible for investigating and documenting domestic complaints on OSTA products. This position directs activities associated with escalated complaints to ensure timely closure of investigations and works closely with MDR analysts to support efficient MDR investigation decisions.
This position will also work with the Complaint Systems Data team to monitor market trends and complaint system relationships to lead product improvement initiatives, monitoring of complaint related systems, and remediation activities in close collaboration with Olympus manufacturing sites.
Job Duties
Responsible and accountable for Complaint activities for OSTA. This includes management and execution of OSTA PMS procedures, local work instructions, practices and compliance of complaint and reporting performance, working in a cross-functional team with other OSTA management/departments.
Responsible and accountable for the Complaint Systems Data activities for the Americas. This includes complaint handling relationships processes and system relationships, as well as the management administration of the quality and data monitoring program, remediation programs, and organizing complaint handling activities through project management.
Responsible to support as required 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 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 OSTA 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/MDRs.
Job QualificationsRequired:
Bachelor of Science, medical, engineering, or scientific discipline or equivalent.
Minimum of 10 years management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR) compliance and quality assurance.
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.
Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Preferred:
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.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Diversity Equity & Inclusion Initiatives including Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
#J-18808-Ljbffr
Field
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.
Job DescriptionThe Complaint Director is responsible for establishing and maintaining a complaint handling process inclusive of complaint investigations and system which is compliant to US FDA regulations for complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803.3), ISO 13485:2016 (EMEA), Canadian & Brazilian vigilance reporting. This position will be responsible for maintaining compliance to OCI & LATAM requirements.
The Complaint Director shall have direct leadership, accountability, and oversight of a Post Market Surveillance system responsible for investigating and documenting domestic complaints on OSTA products. This position directs activities associated with escalated complaints to ensure timely closure of investigations and works closely with MDR analysts to support efficient MDR investigation decisions.
This position will also work with the Complaint Systems Data team to monitor market trends and complaint system relationships to lead product improvement initiatives, monitoring of complaint related systems, and remediation activities in close collaboration with Olympus manufacturing sites.
Job Duties
Responsible and accountable for Complaint activities for OSTA. This includes management and execution of OSTA PMS procedures, local work instructions, practices and compliance of complaint and reporting performance, working in a cross-functional team with other OSTA management/departments.
Responsible and accountable for the Complaint Systems Data activities for the Americas. This includes complaint handling relationships processes and system relationships, as well as the management administration of the quality and data monitoring program, remediation programs, and organizing complaint handling activities through project management.
Responsible to support as required 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 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 OSTA 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/MDRs.
Job QualificationsRequired:
Bachelor of Science, medical, engineering, or scientific discipline or equivalent.
Minimum of 10 years management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR) compliance and quality assurance.
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.
Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
Preferred:
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.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Diversity Equity & Inclusion Initiatives including Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
#J-18808-Ljbffr