Principal QA Engineer: Design Control & CAPA Leader

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

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.