At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today!
We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year!
Description: This position is a key role in ensuring product and quality system documentation meets defined quality standards requirements. The Document Control Specialist will be responsible for ensuring that all documents and records, in support of design controls, risk management, and production controls, comply with applicable global regulations and standards, including but not limited to FDA Quality Management System Regulations, ISO 13485:2016.
Responsibilities, Skills & Hands-On Experience:
- Work with Quality, Regulatory and other cross functional team members to drive the implementation of electronic quality management system (QMS).
- Manage document control and training functions, including processing of change orders and training matrix updates.
- Manage record retention requirements for all quality management system elements, including but not limited to, change orders, training records, receiving and incoming inspections records and supplier files.
- Prepare and run weekly CCB meetings with follow-up the following week.
- Responsible for generating ECO KPI data.
- Participate in both internal and external audits and inspections.
Education & Work Experience:
- Bachelor’s degree preferred with a minimum of 5 years of experience in document and record control in FDA regulated industries (medical device industry experience is preferred).
- Must have experience with an electronic Quality Management System.
- Must be proficient in MS Office Suite.
- Strong communication skills.
- Demonstrated ability to support multiple projects.
