Principal Quality Assurance Engineer

Philips International; Gainesville (FL); On-site; USD 120,000 - 170,000; Full time

Job summary

Philips, a health technology company, is seeking a Principal Quality Assurance Engineer in Gainesville, FL to plan and execute comprehensive process validation strategies using statistical tools to ensure smooth transition of new products to production while meeting quality and regulatory standards.

The role leads the design control process across the product lifecycle, drives CAPA and PMS activities, and guides risk management to maintain product safety and quality, with onsite work and

Qualifications

• Bachelor's or Master's degree in engineering or science.
• 5+ years of experience in medical device quality, design QA, risk management, or equivalent.
• 8+ years of experience with medical device regulations and Design Quality Management.

Responsibilities

• Plans and executes comprehensive process validation strategies using statistical tools.
• Leads the design control process from inputs to design transfer, ensuring regulatory compliance.
• Leads quality improvement projects and CAPA processes across the product lifecycle.
• Validates critical design inputs: usability, reliability, manufacturability, and safety.
• Guides risk management activities to identify, assess, and mitigate risks.

Skills

Quality assurance

CAPA

Root cause analysis

Data analysis

Risk management

Design control

Regulatory standards

Education

Bachelor's or Master's degree in engineering/science

Tools

Statistical tools

Job description

Job Title: Principal Quality Assurance Engineer

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.

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 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.

Equal Employment Opportunity

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

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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