Quality Assurance Engineer

Engineer to join our medical device manufacturing team. This role drives quality assurance activities, ensures process excellence, and maintains compliance with regulatory standards. The ideal candidate will lead continuous improvement initiatives and collaborate cross-functionally to guarantee product integrity and customer satisfaction.

Key Responsibilities:

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

• Develop and monitor process controls (SPC), capability studies, and validation protocols (IQ/OQ/PQ)

• Support nonconformance investigations, MRB decisions, and material disposition

• Interface with design, manufacturing, and regulatory teams on new product introductions and process changes

• Conduct internal audits and prepare for regulatory inspections (FDA, ISO, MDSAP)

• Author and revise quality system documents, procedures, and work instructions

• Mentor junior engineers and technicians; promote quality culture on the production floor

• Collaborate with suppliers to ensure incoming product quality and compliance

• Lead Lean, Six Sigma, and Kaizen initiatives to improve yield and reduce defects

Qualifications:

• Bachelor's degree in engineering or related field (Mechanical, Biomedical, Industrial preferred)

• 5+ years of experience in medical device manufacturing quality

• Strong knowledge of FDA QSR, ISO 13485, MDSAP, and EU MDR

• Hands-on experience with product safety marking approvals (e.g., UL, CE), registration maintenance, and global regulatory submissions

• Exposure to FDA inspections, regulatory audits, and product registration processes

• Proficient in quality risk management, process validation (IQ/OQ/PQ), and statistical tools (e.g., Minitab)

• Excellent analytical, communication, and documentation skills

• Bilingual (Spanish/English) a plus

"Creating better together". It's Enovis' purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short on creating the next generation of better together at Enovis:

Better is... | Enovis

We offer a comprehensive benefits package which includes:

• Medical Insurance

• Dental Insurance

• Vision Insurance

• Spending and Savings Accounts

• 401(k) Plan

• Vacation, Sick Leave, and Holidays

• Income Protection Plans

• Legal Services

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit https://www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit https://www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.