Sr. Quality Systems Manager

Philips; Malvern (Chester County); On-site; USD 109,000 - 180,000; Full time

Job summary

Philips is seeking a Sr. Quality Systems Manager to oversee QMS compliance and lead strategic initiatives within the AM&D Organization. This role involves managing quality processes, ensuring compliance with FDA regulations, and transforming current systems into a unified structure. The ideal candidate will have extensive experience in the medical device industry and a strong educational background in a scientific or technical field.

Benefits

PTO

401k

HSA

Stock purchase

Qualifications

• 5+ years in the medical device industry.
• Minimum 3 years of managerial experience.
• Experience with software validation.

Responsibilities

• Manage QMS compliance and effectiveness.
• Lead transformation towards a unified PQMS structure.
• Develop transition plans for QMS in scope.

Skills

GMP knowledge

Analytical troubleshooting

Education

Bachelor’s degree in a scientific or technical field

Job description

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Job Description

Job Title: Sr. Quality Systems Manager

Role Overview: Manage global alignment and simplification for the AM&D Organization. Oversee QMS compliance and provide strategic recommendations to management and business category leaders.

Responsibilities:

1. Maintain, enforce, and manage a compliant and effective QMS for scope activities, ensuring lean structures and documentation for Q&R processes at all levels.
2. Lead the transformation of current QMS components towards a unified PQMS structure.
3. Develop and execute transition plans for all QMS in scope, maintaining compliance and effectiveness, including external audits (FDA, Notified Bodies).
4. Manage Q&R processes, ensuring process ownership and document management aligned with PQMS evolution.

Qualifications:

• Bachelor’s degree in a scientific or technical field.
• 5+ years in the medical device industry with strong knowledge of GMPs and FDA regulations.
• Minimum 3 years of managerial experience leading teams and implementing organizational projects.
• Experience with software validation, analytical troubleshooting skills.
• Ability to work in an office/remote setting with environmental considerations.

Work Environment & About Philips:

We believe in collaboration. Office roles require working onsite 3 days/week. Philips is a health technology company committed to accessible healthcare for all.

Compensation & Benefits:

In Malvern, PA, the pay range is $109,000 – $180,000 annually. Compensation varies based on experience, location, and other factors. Benefits include PTO, 401k, HSA, stock purchase, and more.

Additional Information:

US work authorization required. No relocation benefits. Reside within commuting distance to Malvern, PA. Application window is approximately 45 days.

Job Details:

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Hospitals and Health Care