Vigilance Manager-Post Market Surveillance

Location Type: On-site

 

Job Title
Vigilance Manager-Post Market Surveillance

Job Description

The Vigilance Manager is a key member of our Sleep & Respiratory Care Post Market Surveillance Operations organization, accountable for managing a team responsible for evaluating, investigating, and resolving complaints and upholding high standards of service quality and customer satisfaction.

Your role:

• Manages a team of complaint investigators across PMS Operations team, acts as an advisor, providing guidance to meet schedules and/or resolve technical problems, drives employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Guides a team of reviewers, responsible for evaluating, investigating, and resolving complaints, conducting initial assessments of reportability, and escalating to the manager when necessary, ensuring comprehensive resolution and effective management of both product and non-product matters. Oversees complaint team’ review and accuracy in applying appropriate coding to service records, ensuring the integrity and efficiency of the overall complaint handling system.
• Initiates and formulates complaint operations policies and establishes procedures that impact the immediate organization(s), recommending changes as necessary to enhance operational efficiency and effectiveness.
• Escalates issues to senior management for additional consideration or decision-making, ensuring that significant matters are brought to the attention of higher authorities for appropriate resolution in alignment with organizational objectives and priorities.
• Establishes an effective management review process and incorporates routine reporting mechanisms to ensure ongoing evaluation and oversight of organizational performance and objectives. Prepares comprehensive reports analyzing complaint trends, resolutions, and the efficacy of corrective actions implemented to enhance service quality and customer satisfaction.
• Monitors complaint resolution timelines to ensure strict adherence to established service level agreements, utilizes PMS tools effectively to track progress and identify areas for improvement, upholding high standards of service quality and customer satisfaction.
• Conducts training sessions for staff, equips them with complaint handling knowledge and high standards of customer service, ensuring timely and effective responses to customer issues, thereby fostering a culture of excellence in customer relations within the team.

You’re the right fit if:

• You have a minimum of 7+ years’ experience in Post Market Quality within FDA regulated medical device environments, with a focus on Complaint Handling and Vigilance Reporting.
• You’ve acquired a minimum of 2+ years’ experience in leadership of Post Market/Complaint Handling teams, including training in complaint handling knowledge, ensuring timely and effective responses to customer issues, fostering a culture of continuous improvement/excellence in customer relations within the team.
• You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
• You have strong written/oral communications skills in English and the ability to effectively communicate with a variety of internal and external audiences (e.g. Authorities, customers)
• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines. ASQ certifications -desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

How we work together:

We believe that we are better together than a part. 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 of 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 Cambridge, MA is $97,440 to $155,904.
• The pay range for this position in New Kensington, PA is $87,000 to $139,200.

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.

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.

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.

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 Cambridge, MA or New Kensington, PA.
• This role may require travel up to 10%.

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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.