Sr. Quality Systems Manager

Job Title

Job Description

Sr. Quality Systems Manager

In this role you

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

Your role:

• Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels of business.
• Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.
• Establishes and executes a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. Assume external audit support (FDA, Notified Body, and other external audit support).
• Manages Q&R processes and ensures process ownership for all activities under the scope of the PQMS governance model. Ensures the addition and management of any QMS documents in line with the evolution of the PQMS.

You're the right fit if:

• Bachelor’s degree in a scientific or technical field
• 5+ years of experience in the medical device industry.  Strong working knowledge of GMP’s and other FDA regulations
• Experienced manager with a minimum of 3 years of experience leading teams and delivering on organizational objectives. Experience managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.
• Experience with non-product software validation. Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
• 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 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 Malvern, PA is $109,000 – 180,000, 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 Malvern, PA.

#LI-PHI

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.