Principal Quality Engineer

Enovis • Austin, TX

17h

About The Position

As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. In this senior role, you will leverage your extensive experience in medical device quality to lead projects improving product quality performance, drive cost-efficient quality initiatives, ensure patient safety through compliance, and support new product introductions from a quality standpoint. As a Principal Quality Engineer, you will serve as a key quality authority on cross-functional teams, mentoring others and guiding strategic quality improvements to help Enovis "create better together" in healthcare.

Requirements

• Education: Bachelor’s degree in engineering or related field (mechanical, biomedical, industrial engineering, or similar) required. An advanced degree (MS in Engineering or MBA) is a plus.
• Experience: 10+ years of experience in Quality Engineering, Quality Assurance, or a related engineering role, with significant experience in validation engineering within medical devices or other regulated industries. Demonstrated track record of leading quality or process improvement projects and driving measurable improvements in product quality and compliance.
• Quality & Regulatory Knowledge: In-depth knowledge of ISO 13485 quality management systems and FDA Quality System Regulation (21 CFR Part 820) requirements. Strong understanding of risk management (ISO 14971), design control requirements, and validation/verification processes for medical devices. Experience participating in FDA or ISO audits is highly desirable.
• Technical Skills: Proficiency with quality engineering tools and methodologies: ability to perform root cause analysis (e.g., 5 Why, fishbone), lead Failure Mode and Effects Analysis (FMEA), and apply statistical techniques (SPC, DOE, Gage R&R) for problem-solving. Experience with validation of processes/equipment and change control in manufacturing. Comfortable using data analysis software and presenting data-driven insights.
• Leadership & Communication: Excellent communication skills, both written and verbal, with experience writing clear technical reports/protocols and quality documentation. Proven ability to collaborate across multidisciplinary teams and to influence without direct authority. Able to project manage multiple initiatives and meet deadlines, demonstrating a high level of organization and “ownership” of quality outcomes.

Nice To Haves

• Advanced Credentials: Master’s degree in Engineering or Quality Management. ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt, or similar professional certification
• Industry Experience: Experience in orthopedic implants or surgical instruments quality engineering is a strong plus (familiarity with biomechanical product standards, sterilization processes, and biocompatibility considerations)
• Process Improvement Leadership: Demonstrated leadership of Lean or Six Sigma projects resulting in significant quality, safety, or cost improvements. Participation in cross-site or global quality improvement initiatives. Recognition or awards for quality excellence or continuous improvement contributions would be advantageous.
• Software/Tools: Working knowledge of quality system software (e.g., electronic QMS, statistical analysis tools) and general business software. Competency in reading engineering drawings and GD&T; experience with metrology for precision components is beneficial.

Responsibilities

• Lead the development and execution of quality and validation master plans, protocols (IQ/OQ/PQ), and reports for equipment, utilities, software, and manufacturing processes. Ensure validation activities comply with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
• Lead Quality Improvement Projects: Identify and drive continuous improvement initiatives to enhance product quality and reliability (e.g. reducing defect rates, improving yield). Utilize data from audits, non-conformance reports, and process metrics to prioritize and implement improvements
• Drive Cost Efficiency in Quality Processes: Implement Lean Six Sigma methodologies to reduce the cost of poor quality (scrap, rework, warranty claims) and improve operational efficiency
• Ensure Patient Safety and Compliance: Champion rigorous risk management and quality assurance practices to ensure all products meet safety and regulatory requirements
• Support New Product Introduction (NPI): Collaborate with R&D and Operations on new product development teams to integrate quality at every phase. Lead quality planning for new products, including establishing design input requirements for quality, validating new manufacturing processes, and ensuring design transfer is executed with robust controls
• Cross-Functional Collaboration: Work closely with Manufacturing, Engineering, Supply Chain, and Product Development teams to drive quality objectives. Facilitate design and process reviews with cross-functional stakeholders
• Technical Leadership & Mentorship: Serve as a technical lead and mentor for the Quality Engineering team. Provide guidance on complex quality issues and share best practices in areas like root cause analysis, statistical process control, and validation
• Supplier Quality Assurance: Partner with Supplier Quality and Procurement teams to ensure suppliers meet Enovis’ quality standards. Assist in developing incoming inspection requirements and supplier quality agreements, and provide quality engineering expertise for supplier process changes or new component qualifications
• Quality System Management: Author and revise quality system documents (procedures, work instructions) related to product quality, ensuring they reflect best practices and regulatory requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees