Service Quality Engineer

Philips; Gainesville (FL); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

PTO (paid time off)

401k with match

HSA with company contribution

Stock purchase plan

Job summary

Philips is seeking a Service Quality Engineer in Gainesville, FL, to bridge quality management systems with service delivery and ensure regulatory and internal standards are met.

The role involves supporting QMS activities, driving process improvements, and participating in audits, CAPA, and risk management for medical-device related services. Office-based, onsite with a strong emphasis on compliance and quality processes.

Qualifications

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Responsibilities

• Support QMS activities across departments and sites
• Lead or participate in process-improvement initiatives
• Support audits and ensure compliance with ISO 13485, MDSAP, MDD, EU-MDR, CFR
• Initiate and manage CAPA to address defects and non-conformances
• Apply risk assessment to service processes
• Assess PFMEA impact with design changes and assist in service design transfer

Skills

Quality engineering

Process engineering

Safety engineering

2+ years experience

Education

Bachelor's/Master's in Engineering or Science

Job description

Job Title

Service Quality Engineer

Job Description

Service Quality Engineers help bridge the gap between quality management systems (QMS) and service delivery, ensuring that customer needs, regulatory requirements, and internal standards are met.

Your Role

• Quality Management System (QMS) Support: Facilitate and manage QMS activities across departments, sites, and businesses. Process Improvement: Lead or participate in initiatives to improve service and delivery processes, often under a regulatory scope
• Audits & Compliance: Support internal and external audits, ensuring adherence to standards such as ISO 13485, MDSAP, MDD, EU-MDR, and CFR
• Corrective & Preventive Actions (CAPA): Initiate and manage CAPA to address defects, non-conformances, and quality notifications
• Risk Management: Apply risk assessment tools and principles to service and delivery processes
• Software Quality : For roles involving software as a medical device, assess design, review tests, analyze market feedback, and perform root cause analysis
• Conducts assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Service Process Development and Design Transfer activities to Service.

You're The Right Fit If

• Bachelor's/Masters Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education.
• 2+ years of experience in Quality Engineering, Safety Engineering, Process Engineering or equivalent with Bachelor’s degree.
• We prefer 3+ years of experience in medical device, Process Engineering.
• 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 Gainesville FL is $92,000 to $130,000 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 Gainesville FL.

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.