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- Tasks: Lead a team ensuring product quality and patient safety through effective corrections and removals management.
- Company: Philips is a global health technology leader dedicated to improving healthcare access and quality for everyone.
- Benefits: Enjoy generous PTO, 401k matching, education reimbursement, and more in a supportive work environment.
- Why this job: Join a mission-driven company where your work directly impacts lives and fosters innovation in healthcare.
- Qualifications: 8+ years in FDA regulated post-market surveillance with strong leadership and communication skills required.
- Other info: This role requires onsite presence at least 3 days a week in New Kensington, PA.
The predicted salary is between 80000 - 120000 £ per year.
Senior Manager-Corrections & Removals page is loaded
Senior Manager-Corrections & Removals
Apply locations New Kensington time type Full time posted on Posted 8 Days Ago job requisition id 559820
Job Title
Senior Manager-Corrections & Removals
Job Description
The Senior Manager-Corrections & Removals (C&R) will manage a team of C&R specialists performing recall reporting, tracking, and process execution, as well as managing the C&R review board agenda and facilitating C&R decisions, playing an important role in ensuring Sleep & Respiratory Care product quality and patient safety.
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 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 New Kensington, PA is $114,750 to $183,600.
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 New Kensington, PA .
- This role may require travel up to 10%.
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.
About Us
At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.
For more than 130 years, we have been creating technologies and innovations that improve people\’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
Together, we deliver better care for more people because we believe that every human matters. That\’s why we\’re taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other\’s views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.
It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.
To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans\’ Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
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Senior Manager-Corrections & Removals employer: Philips International
Contact Detail:
Philips International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager-Corrections & Removals
✨Tip Number 1
Familiarise yourself with the latest FDA regulations and guidelines related to Corrections & Removals. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and quality excellence.
✨Tip Number 2
Network with professionals in the Post Market Surveillance field, especially those who have experience in C&R processes. Engaging with industry peers can provide valuable insights and may even lead to referrals for the position.
✨Tip Number 3
Prepare to discuss specific examples of how you've driven performance improvements in previous roles. Highlighting your strategic leadership skills and successful project outcomes will set you apart from other candidates.
✨Tip Number 4
Research Philips' culture and values, particularly their commitment to health technology and patient safety. Tailoring your conversation to align with their mission can show that you're a great fit for their team.
We think you need these skills to ace Senior Manager-Corrections & Removals
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in FDA regulated post-market surveillance and corrections & removals. Use specific examples that demonstrate your leadership skills and knowledge of relevant regulations.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the job description. Emphasise your strategic initiatives and how they have enhanced C&R processes in your previous roles. Show your passion for quality excellence and continuous improvement.
Highlight Relevant Experience: In your application, clearly outline your 8+ years of experience in the field. Mention any specific projects or achievements that align with the responsibilities of managing a C&R team and ensuring compliance with regulatory standards.
Showcase Soft Skills: Don’t forget to mention your strong communication and collaboration skills. Provide examples of how you have successfully led teams and facilitated meetings with stakeholders to gather insights and expectations.
How to prepare for a job interview at Philips International
✨Showcase Your Leadership Experience
As a Senior Manager, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully managed teams, driven performance, and mentored subordinates in previous roles.
✨Understand Regulatory Requirements
Familiarise yourself with FDA regulations and global medical device standards relevant to Corrections & Removals. Be ready to discuss how you have ensured compliance in past projects and how you would approach regulatory inquiries.
✨Highlight Continuous Improvement Initiatives
Prepare to discuss specific instances where you've implemented strategies for enhancing efficiency in C&R processes. Use metrics or KPIs to illustrate the impact of your initiatives on product quality and patient safety.
✨Engage with Stakeholders
Since the role involves leading meetings with senior stakeholders, practice articulating how you gather insights and align expectations. Be prepared to share your approach to developing standardised processes that facilitate effective communication and collaboration.
