Principal Quality Assurance Engineer

About the role

Job Title

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.

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.