Head of Postmarket Surveillance, Oral Healthcare

Philips • Bothell, WA

17h • Onsite

About The Position

Head of Postmarket Surveillance, Oral Healthcare In this role you You are responsible for overseeing all aspects of post-market surveillance, including process implementation, complaint handling, and corrective and removal activities. Your role: Drive monitoring, support enhancement and implementation of post-market surveillance, complaint handling, and correction and removal processes and activities, ensuring compliance with regulatory standards and organizational policies. Drive cross-functional periodic reviews and collaboration with stakeholders, integrating feedback and lessons learned into product development and improvement, processes improvements and strategic initiatives. Analyze and refine key operational metrics and reporting systems and ensure data-driven decision-making for continuous improvement. Lead and oversee quality metrics for trending purposes, and reports on trending, post market surveillance activities, periodic safety reports etc. Lead investigations into product complaints and adverse events, ensure timely reporting, accurate triage, escalation, and resolution, and oversee corrective/removal actions to maintain product safety and regulatory compliance. Lead, manage and develop a multidisciplinary team. Foster a culture of transparency and accountability, mentoring team members and ensuring the effective transfer of knowledge and best practices throughout the organization. You're the right fit if: Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent. 5+ years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent. Preferred experience in Risk management experience for medical devices, with thorough knowledge of FMEAs and RMRs, Minimum 3 years’ prior management or other relevant experience, Experience with FDA inspection, and/or ISO Audits, NCR, FSN and CAPA experience is a plus, Experience in both medical and non-medical is a plus, Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business . Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in Bothell, WA is $128,520 to $180,000 Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here . At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Requirements

• Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 5+ years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
• Minimum 3 years’ prior management or other relevant experience
• Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to Bothell, WA.

Nice To Haves

• Preferred experience in Risk management experience for medical devices, with thorough knowledge of FMEAs and RMRs
• Experience with FDA inspection, and/or ISO Audits, NCR, FSN and CAPA experience is a plus
• Experience in both medical and non-medical is a plus

Responsibilities

• Drive monitoring, support enhancement and implementation of post-market surveillance, complaint handling, and correction and removal processes and activities, ensuring compliance with regulatory standards and organizational policies.
• Drive cross-functional periodic reviews and collaboration with stakeholders, integrating feedback and lessons learned into product development and improvement, processes improvements and strategic initiatives.
• Analyze and refine key operational metrics and reporting systems and ensure data-driven decision-making for continuous improvement.
• Lead and oversee quality metrics for trending purposes, and reports on trending, post market surveillance activities, periodic safety reports etc.
• Lead investigations into product complaints and adverse events, ensure timely reporting, accurate triage, escalation, and resolution, and oversee corrective/removal actions to maintain product safety and regulatory compliance.
• Lead, manage and develop a multidisciplinary team.
• Foster a culture of transparency and accountability, mentoring team members and ensuring the effective transfer of knowledge and best practices throughout the organization.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees