Principal Quality Assurance Engineer

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

Benefits offered by this job

Annual incentive bonus

Stock purchase plan

Education reimbursement

401k with match

HSA

PTO

Job summary

Philips in Gainesville, FL is seeking a Principal Quality Assurance Engineer to lead the design control process, plan and execute comprehensive process validation, and drive CAPA and risk management across the product lifecycle.

The role emphasizes validation, regulatory alignment, and optimization of product quality with PMS integration, in an office-based environment. This is a full-time onsite position with potential incentives and benefits.

Qualifications

• Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 5+ years of experience with Bachelor's in 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.
• US work authorization is a precondition of employment; office/remote position requirements.

Responsibilities

• Plan and execute 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.
• Lead 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.
• Lead 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.

Skills

Process validation

Design control

CAPA

Root cause analysis

Quality assurance

Risk management

Data analysis

Education

Bachelor's/Master's degree

Tools

Statistical tools

Job description

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.

Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program,

• In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.
• 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.