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Sr. QMS Engineer

Roles & Responsibilities

  • Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent
  • 7+ years of experience with a Bachelor's degree or 5+ years with a Master's in Quality Management Systems, Quality Audits, or equivalent in highly regulated environments (e.g., medical devices, pharma, automotive)
  • Preferred experience with Quality, QMS, CAPA, and Risk Management in a Medical Device context
  • Strong communication and cross-functional collaboration skills

Requirements:

  • Deploy and maintain a compliant QMS; analyze complex QMS data, prepare detailed reports, and present findings to leadership
  • Own moderately complex processes within audits, document control, training, and CAPA to ensure QMS efficiency and regulatory compliance
  • Act as a liaison between the QMS team and other departments to ensure effective communication and alignment of QMS activities with business objectives and regulatory requirements
  • Provide guidance to project teams on quality plans, risk assessments, and process validations, and coordinate external regulatory audits and responses to audit findings in collaboration with stakeholders

Job description

Job Title

Sr. QMS Engineer

Job Description

Sr. QMS Engineer

In this role you

Are responsible for the deployment and proper functioning of a compliant Quality Management System (QMS). The role analyzes complex QMS data, prepares detailed reports, and presents findings to leadership.

Your role:

• Takes ownership of moderately complex processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements.
• Analyzes and interprets QMS performance data to identify trends, process inefficiencies, and potential areas for improvement, and presents findings to management with recommendations for action.
• Acts as a key liaison between the QMS team and other departments to ensure effective communication, collaboration, and alignment of QMS activities with business objectives and regulatory requirements.
• Provides expert guidance and support to project teams in developing quality plans, risk assessments, and process validations to ensure compliance with QMS and regulatory expectations.
• Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

You're the right fit if:

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 7+ years of experience with Bachelor's OR Minimum 5 years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.
  • Prefer experience with Quality, QMS, CAPA, Risk Management in a Medical Device.
  • 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.

Philips Transparency Details

The pay range for this position in Reedsville PA is $114,750 to $160,000 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 Reedsville, 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.

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