Sr QA Manager, Distribution & Warehouse

Regulatory Jobs; Mount Pleasant (Westmoreland County); On-site; USD 120,000 - 170,000; Full time

Job summary

Philips in Mount Pleasant, PA, seeks a Sr QA Manager for Distribution & Warehouse to lead quality initiatives across operations, monitor KPIs, and drive regulatory compliance.

You will manage supplier quality, oversee recalls, and lead audits to ensure FDA readiness for distribution and warehouse facilities. The role requires a Bachelor’s or Master’s in quality-related fields and 5+ years of medical device quality leadership.

Qualifications

• Bachelor's or master's degree in a relevant field (Quality Management, Engineering, Science)
• 5+ years' experience in medical device quality systems, leadership, QA/QC, CAPA, audits
• Strong knowledge of regulatory standards, FDA readiness, and data-driven quality improvements

Responsibilities

• Lead quality objectives for distribution and warehouse operations.
• Manage supplier quality and oversee third-party warehouse quality activities.
• Oversee product recalls, inspections, and adherence to approved manufacturing processes.
• Lead internal and external audits and close regulatory gaps.
• Ensure compliance with company standards, regulations, and QMS requirements.

Skills

Leadership

QMS Management

CAPA

Root Cause Analysis

Data Analysis

Regulatory Compliance

Audits

Quality Audits

Supplier Quality

Education

Bachelor's / Master's Degree in Quality Management, Engineering or Science

Job description

Job Title

Sr QA Manager, Distribution & Warehouse

Job Description

In this role you

Are responsible for orchestrating operational objectives and plans, monitoring KPIs, resolving complex quality assurance issues, managing supplier processes, overseeing product recalls, maintaining supplier quality, and leading talent management within the organization to drive productivity and alignment with company goals.

Your role:

• Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes. Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Partner with Supplier Quality Assurance for the establishment and oversight of third party contracted warehouses, inspection plan set up, incoming inspection requirements.
• 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.
• Utilizes wide-ranging experience and professional expertise, creatively resolves complex issues aligned with company objectives, distinguished by additional specialized knowledge and recognized as an expert in the field.
• Guides the review and approval of finished products manufactured for and by the company, manages all inspections and inquiries regarding the operation of manufacturing sites and collaborates with relevant company groups to ensure compliance with company standards, regulations and approved manufacturing process specifications. Leads external and internal audits, aids in regulatory compliance gap closure.
• Support new, integration, and transfer projects while assuring regulatory compliance and FDA readiness for distribution and warehouse facilities. Leads external and internal audits, aids in regulatory compliance gap closure.

You're the right fit if:

• Bachelor's / Master's Degree in Quality Management, Supply Chain Management, Engineering, Science or equivalent.
• 5+ years of experience with Bachelor's in areas such as Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent.
• We prefer 5+ years of experience with medical device regulations and standards, Leadership, QMS Management, Quality Audits, CAPA, Root Cause Analysis, Data Analysis.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

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.

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 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 Mount Pleasant PA is $120,000 to $170,400 Annually.

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.

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.

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.

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 Mount Pleasant PA.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.