Principal Quality Assurance Engineer

Regulatory Toolkit; Gainesville (FL); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO

401k

HSA

Stock purchase plan

Education reimbursement

Descripción de la vacante

Philips is seeking a Principal Quality Assurance Engineer in Gainesville, FL to lead the full design control process and ensure regulatory compliance. The role focuses on validation, verification, and design transfer, with emphasis on CAPA, risk management, and data-driven quality improvements.

Office-based role requiring in-person collaboration. The ideal candidate has extensive experience in medical device QA, design quality, and PMS considerations, with strong problem-solving and

Formación

• Bachelor's/Master's in Mechanical, Electronics, Science or equivalent.
• 5+ years in Medical Device QA/Design Quality Assurance or equivalent with Bachelor's.
• 8+ years of experience with medical device regulations, Design Quality Management, Design for Quality, Root Cause Analysis, CAPA, Data Analysis.

Responsabilidades

• Lead and manage the entire design control process from inputs to verification, validation and transfer.
• Plan and execute process validation strategies using statistics for product transfers to production.
• Record, manage and execute CAPA processes including root cause analysis and implementing solutions.
• Guide risk management activities across the product lifecycle to ensure safety and quality.

Conocimientos

Design control

CAPA

Risk management

Data analysis

Regulatory knowledge

Root cause analysis

Educación

Bachelor's degree or higher in engineering/science

Descripción del empleo

Job Title

Principal Quality Assurance Engineer

Job Description

In this role you

The role handles the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer.

Your role:

Plans and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
Leads quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability. Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.

You're the right fit if:

• Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.


• 5+ years of experience with Bachelor's in areas such as Medical Device, Design Quality Assurance, Risk Management, Quality Control, Quality Audit, or equivalent.


• We prefer 8+ years of experience with medical device regulations and standards, Design Quality Management, Design for Quality, Root Cause Analysis, CAPA Methodologies, Data Analysis.


• 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 $120,000 to $170,400 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

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.