- Management Representative for Quality Management System.
- Oversee and manage compliance of regulations that pertain to Design and Manufacturing of medical devices (FDA, ISO 13485, MDSAP, RoHS.) Stay current with new and changing regulations.
- Provide guidance and interpretation for additional regulations such as IEC 62304, ISO 14971 as needed.
- Provide Quality support to manufacturing, engineering, and support operations through the administration, collection, analysis of data, and the industry standards associated with each product line.
- Ensure QMS support system, including IT infrastructure, tools, software and systems are compliant with industry regulations and standard practices.
- Manage and lead FDA, ISO, Customer, Safety Agencies, and other third party audits.
- Manage internal audit and layered process audit programs.
- CAPA, advisory notice and complaint management.
- Oversight of Validation, Change Control, and Temporary Deviation activity.
- Manage weekly/monthly quality metrics.
- Manage CAT/PPT meetings.
- Prepare and lead Quarterly Management Reviews.
- Oversees Quality related training to appropriate personnel.
- Manage and develop Quality department employees’ job performance.
- Bachelor’s degree in engineering or relevant field.
- 5 years of experience in a relevant Quality/Regulatory position in the medical device industry or equivalent experience.
- Expertise in medical device laws and regulations (ISO 13485 and FDA CFR).
- Good working knowledge of quality statistical techniques.
- Expertise in software programs such as Windows Word, Excel, PowerPoint.
- Strong communication and training skills.