Senior Manager-Post Market Quality

The Senior Manager-Post Market Quality plays an important role within Philips Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment of quality issues for Recall/Correction & Removal decisions.

Your role:

• Establishes Post Market Quality operational objectives/work plans, delegates assignments to subordinates to ensure smooth execution/efficient distribution of tasks within the organization and fosters collaboration/productivity while aligning with overarching goals. Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
• Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.
• Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.
• Directs product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the device issue evaluations for decision and recall process (if applicable) to maintain compliance and uphold consumer safety.
• Supports in external and internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality metrics, agreements, and records.
• Formulates/implements the Business’ long-range quality, regulatory and compliance policy and creates Q&R awareness level as determined within the organization.
• Enforces (a simplified) quality system and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting with action for negative trends.
• Manages: compliance with FDA regulations/Regulatory Agencies guidelines and policies, the review and approval of finished products in accordance with approved specifications (includes Complaint handling) and product recall activities to include recall policies and procedures for the company.

You're the right fit if:

• You’ve acquired a minimum of 10+ years’ experience in Post Market Quality within FDA regulated medical device/product environments, with proven experience in Quality Planning, Complaint Handling, returns, investigations, Corrections & Removals, Recalls, QMS simplification/harmonization, CAPA’s, Internal/External Audit-compliance to FDA regulations/Regulatory Agencies guidelines and policies.
• You have a minimum of 3+ years’ experience managing Post Market Quality teams, including employee selection, performance management, compensation management, career development, effective operational management and fostering a culture of continuous improvement/quality 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’ve acquired a minimum of a Bachelor’s Degree (required) in Engineering, Quality or related disciplines. Master’s degree desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

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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.

Philips Transparency Details:

• The pay range for this position in Colorado Springs, CO 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

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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 Colorado Springs, CO.

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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.