Philips Senior Manager-Corrections & Removals 

United States, Pennsylvania 

72554969

Your role:

• Will Manage the C&R team, driving employee selection, performance/ compensation management, career development, and ensure effective operational management. Serves as a mentor to subordinates, provides advanced guidance to meet deadlines and address complex technical challenges effectively, and oversees the development and implementation of schedules and performance criteria to ensure project success.
• Analyzes Key Performance Indicators (KPIs) to track the effectiveness of C&R processes, identifies areas for enhancement, develops short-term implementation plans and ensures continuous improvement in post-market surveillance activities. Directs support for audits and inspections related to C&R requests, aids in strategy development, oversee regulatory inquiry responses, and reviews these responses to ensure compliance with C&R standards.
• Leads meetings with senior internal/external stakeholders to gather insights and expectations and ensures the development of accurate, precise, and standardized processes for specifying and executing corrective & removal (C&R) tasks. Reviews and refines various sub-system feeders to the process, including complaint handling, engineering change orders, kit suppliers, regulatory submissions, and field deployments.
• Provides pertinent feedback and insights and ensures that lessons from past projects are captured, synthesized, and disseminated to subsequent project teams for informed decision-making and continuous improvement. Utilizes a range of strategies and company objectives to address complex challenges in innovative and effective ways, ensuring optimal resolutions that align with organizational goals and priorities.
• Utilizes a working understanding of relevant global regulations, requirements, and standards to proficiently execute correction and removal tasks, ensuring compliance and swift resolution of issues to uphold product safety and regulatory compliance, fostering transparency and cooperation in the resolution process.

You're the right fit if:

• You’ve acquired a minimum of 8+ years’ experience in FDA Regulated Post Market Surveillance (PMS), with a focus in Corrections & Removals (21 CFR Part 820 (QSR), Part 7, 806, 810) and proven experience implementing strategic initiatives aimed at enhancing the efficiency/effectiveness of C&R processes and maintains strict compliance with regulatory requirements governing product corrections and removals.
• Your skills include proven functional/strategic leadership of Post Market Surveillance/C&R teams, detailed knowledge in FDA and Global Medical Device regulations, strong communication and collaboration skills, with a commitment to Quality excellence and continuous improvement.
• You have ensured accurate and on-time Monthly tracking of open SCR Field Actions and created documents identified in C&R strategies.
• You have a minimum of a Bachelor’s degree (required), in Quality, Regulatory, Technical or Scientific disciplines; Advanced degree (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together:

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.

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Philips Transparency Details:

• The pay range for this position in New Kensington, PA is $114,750 to $183,600.

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