Service Quality Engineer

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

Benefits offered by this job

PTO

401k match

Health Savings Account

Stock purchase plan

Education reimbursement

Job summary

Philips invites applications for a Service Quality Engineer in Gainesville, FL. The role focuses on bridging quality management systems with service delivery to meet customer needs and regulatory requirements.

You will support QMS activities across departments, drive CAPA initiatives, and participate in audits to ensure compliance with ISO 13485, MDSAP, and CFR. Office-based with onsite presence is required.

Qualifications

• 2+ years of experience in Quality Engineering or related fields.
• Experience in medical device or regulated industries preferred.
• Ability to support QMS across departments and sites.
• Office-based role with onsite presence required.

Responsibilities

• Support Quality Management System (QMS) activities across departments, sites, and businesses.
• Lead or participate in process improvement initiatives, often under regulatory scope.
• Assist audits and ensure compliance with ISO 13485, MDSAP, MDD, EU-MDR, and CFR.
• Manage CAPA to address defects, non-conformances, and quality events.
• Apply risk assessment tools to service and delivery processes.
• For software-involved devices, assess design tests and root causes.

Skills

Quality Engineering

Process Engineering

Regulatory knowledge

Risk assessment

Education

Bachelor's degree in engineering or science

Master's degree preferred

Tools

PFMEA

CAPA

Job description

Service Quality Engineer

Job Description

In this role you

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.

#LI-PHI

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