Quality Analyst

Who We Are

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 www.enovis.com.

What You'll Do

This position is responsible for sustaining the change control system (Agile) and supporting all Document Control activities in accordance with DJO’s processes, 21 CFR Part 820 and ISO-13485.

Conducts routine and non-routine analysis of raw materials, in-process items and finished product according to established operating procedures. Compiles data for documentation of test procedures that may include stability program testing and formulation studies. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines. General application of concepts and principals to resolve a variety of issues. Works on problems of a moderate scope where analysis of situation or data requires a review of a variety of factors. Normally receives general instructions on routine work and detailed instructions on new projects or assignments.

ESSENTIAL FUNCTIONS. SPECIFIC RESPONSIBILITIES:

·        Review, route, and release document and part change orders;

·        Monitor status of in-process document changes to ensure timely revisions;

·        Create DOCs for periodic review SOPs;

·        Enter data into ERP system after the change order is released;

·        Ensure projects are completed accurately and on time;

·        Support Quality in both external and internal audits;

·        Support Quality Management to ensure data quality and compliance with cGMPs;

·        Provide Agile trainings as required.

REQUIREMENTS: EXPERIENCE, EDUCATION, SKILLS, AND KNOWLEDGE.

• 3+ years related experience
• Bachelor degree in administration or related career.
• Knowledge of FDA GMPs, ISO 13485 and applicable regulations
• Proficient in Excel, Word, and Outlook
• ERP experience is a plus
• Oracle and Agile experience is a plus
• Ability to multitask, with excellent attention to detail

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria 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.