Senior Quality Assurance Auditor
Medline Industries, LP
Senior Manager, Corrections and Removals
Philips
full-time
Posted on:
Location Type: Office
Location: Massachusetts, Ohio, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Manage a team of C&R specialists performing recall reporting, tracking, and process execution
- Manage the C&R review board agenda and facilitate C&R decisions
- Drive employee selection, performance/compensation management, career development, and ensure effective operational management
- Mentor subordinates and provide advanced guidance to meet deadlines and address complex technical challenges
- Oversee development and implementation of schedules and performance criteria
- Analyze KPIs to track effectiveness of C&R processes and develop continuous improvement plans
- Direct support for audits and inspections related to C&R requests and oversee regulatory inquiry responses
- Lead meetings with senior internal/external stakeholders and ensure standardized processes for C&R tasks
- Review and refine sub-system feeders to the process including complaint handling, engineering change orders, kit suppliers, regulatory submissions, and field deployments
- Capture, synthesize, and disseminate lessons learned to subsequent project teams
- Utilize understanding of global regulations to execute correction and removal tasks ensuring compliance and product safety
Requirements
- 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)
- Proven experience implementing strategic initiatives aimed at enhancing the efficiency/effectiveness of C&R processes
- 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
- Commitment to Quality excellence and continuous improvement
- Ensured accurate and on-time Monthly tracking of open SCR Field Actions and created documents identified in C&R strategies
- Minimum of a Bachelor’s degree (required), in Quality, Regulatory, Technical or Scientific disciplines; Advanced degree (preferred)
- US work authorization is a precondition of employment (the company will not consider candidates who require sponsorship)
- Must reside in or within commuting distance to New Kensington, PA, Orange, OH or Cambridge, MA
- Must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation
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.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Post Market SurveillanceCorrections & RemovalsKPI analysisregulatory complianceperformance managementprocess executionaudit supportcomplaint handlingengineering change ordersregulatory submissions
Soft skills
leadershipmentoringcommunicationcollaborationstrategic thinkingproblem-solvingorganizational skillscommitment to qualitycontinuous improvementfacilitation
