Olympus Corporation of the Americas
Complaints Director
Olympus Corporation of the Americas, Center Valley, Pennsylvania, United States,
Olympus Corporation of the Americas - Complaints Director
Working Location:
PENNSYLVANIA, CENTER VALLEYWorkplace Flexibility:
FieldJob DescriptionThe Complaint Director is responsible for establishing and maintaining a complaint handling process inclusive of complaint investigations and systems compliant with 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 with 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 DutiesResponsible and accountable for Complaint activities for OSTA, including 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 for Complaint Systems Data activities for the Americas, including complaint handling relationships processes and system relationships, as well as management administration of the quality and data monitoring program, remediation programs, and organizing complaint handling activities through project management.Support cross-functional teams (Medical Safety, Field Safety, Manufacturing, and R&D) that evaluate product risk and potential safety issues, ensuring timely initiation and completion of HHEs and regulatory filings if applicable.Hire, develop, and organize a department of engineers, technicians, and medical professionals to meet all requirements efficiently.Work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations performed and documented in HHEs and safety evaluations of products.Partner with Design Quality Assurance to resolve customer issues and develop continuous process improvement initiatives.Develop and implement programs to review literature and the internet for potential complaints and AE/MDRs.Job QualificationsRequired:Bachelor of Science in 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.Experience in developing and leading a top-performing Quality team.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.Equitable Offerings you can count on:Competitive salaries, annual bonus and 401(k) with company match24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance12 Paid HolidaysOn-Site Child Daycare, Café, Fitness CenterConnected Culture you can embrace:Work-life integrated culture that supports an employee-centric mindsetOffers onsite, hybrid, and field work environmentsPaid volunteering and charitable donation/match programsDiversity Equity & Inclusion Initiatives including Employee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational AssistanceAre you ready to be a part of our team?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.Olympus is dedicated to building a diverse, inclusive, and authentic workplaceWe 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.
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Working Location:
PENNSYLVANIA, CENTER VALLEYWorkplace Flexibility:
FieldJob DescriptionThe Complaint Director is responsible for establishing and maintaining a complaint handling process inclusive of complaint investigations and systems compliant with 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 with 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 DutiesResponsible and accountable for Complaint activities for OSTA, including 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 for Complaint Systems Data activities for the Americas, including complaint handling relationships processes and system relationships, as well as management administration of the quality and data monitoring program, remediation programs, and organizing complaint handling activities through project management.Support cross-functional teams (Medical Safety, Field Safety, Manufacturing, and R&D) that evaluate product risk and potential safety issues, ensuring timely initiation and completion of HHEs and regulatory filings if applicable.Hire, develop, and organize a department of engineers, technicians, and medical professionals to meet all requirements efficiently.Work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations performed and documented in HHEs and safety evaluations of products.Partner with Design Quality Assurance to resolve customer issues and develop continuous process improvement initiatives.Develop and implement programs to review literature and the internet for potential complaints and AE/MDRs.Job QualificationsRequired:Bachelor of Science in 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.Experience in developing and leading a top-performing Quality team.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.Equitable Offerings you can count on:Competitive salaries, annual bonus and 401(k) with company match24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance12 Paid HolidaysOn-Site Child Daycare, Café, Fitness CenterConnected Culture you can embrace:Work-life integrated culture that supports an employee-centric mindsetOffers onsite, hybrid, and field work environmentsPaid volunteering and charitable donation/match programsDiversity Equity & Inclusion Initiatives including Employee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational AssistanceAre you ready to be a part of our team?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.Olympus is dedicated to building a diverse, inclusive, and authentic workplaceWe 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.
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