Manager, Quality Engineering

Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

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.

Job Title:

Manager, Quality Engineering

Reports To:

Sr Director, Quality Assurance

Location:

Austin, TX

Business Unit Description:

Recon, Quality

High Level Position Summary:

The Quality Engineering Manager is responsible for leading a team of quality engineers in driving product and process excellence across the surgical device portfolio. This role ensures compliance with regulatory standards, support manufacturing as well as new product introduction and fosters a culture of continuous improvement. The Quality Engineering Manager will collaborate cross-functionally to implement quality strategies that enhance product reliability, reduce risk, and improve operational efficiency.

Key Responsibilities:

• Lead and mentor a team of quality engineers, providing technical guidance and performance management.

• Develop and implement quality strategies that align with business objectives and regulatory requirements.

• Lead quality engineering support for manufacturing operations, ensuring robust process controls, effective risk management, and validation of production methods.

• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.

• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.

• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges and improve processes.

• Support internal and external audits, acting as a subject matter expert for quality engineering practices.

• Maintain and improve quality system documentation, including procedures, work instructions, and validation protocols.

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related field); Master's degree preferred.

• 8+ years of experience in quality engineering within medical devices or other regulated industries, including 3+ years in a leadership role.

• Strong knowledge of ISO 13485, FDA QSR, ISO 14971.

• Proven ability to lead cross-functional teams and manage complex projects.

• Excellent communication, analytical, and problem-solving skills.

• ASQ Certified Quality Engineer (CQE) or Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt.

• Experience with orthopedic implants or surgical instruments.

• Familiarity with eQMS systems, statistical software, and metrology tools.

• Demonstrated success in driving quality improvements and regulatory compliance.