Ortheon is looking for quality candidates for the following position.
Ortheon Medical Careers
Manager of Quality and Regulatory Affairs
JOB DESCRIPTION
Overall control, implementation, and maintenance of the Medical Device quality system and quality procedures in accordance with ISO 9001, ISO 13485, and FDA GMP including:- Quality Assurance and Quality Engineering
- Communication to management on the state of the quality system.
- Direct activities of and evaluating performance of quality associates.
- Administration of document system.
- Monitor and facilitate design control program.
- Oversee implementation of clinical studies as required for submission to regulatory authorities and notified body.
- Generate, coordinate, and monitor required regulatory submissions.
- Registration of devices with all regulatory, and directing the preparation of all submissions to regulatory agencies.
- Perform surveillance and medical device reporting in compliance with MDD, Canadian and FDA regulations.
- Internal and external audit scheduling and reporting.
- Administration of CAPA system.
- Monitor sterilization validation and dose audit processing.
- Monitor storage and distribution of components and finished goods.
- Authorize release of product to distribution after final review of records.
- Respond to customer quality inquiries.
- Review and approve of maintenance and calibration of equipment.
- Monitor the preventative maintenance program for manufacturing equipment and facilities.
- Monitor operating procedures and coordinate training of all manufacturing personnel.
Product Quality
Facilities Monitoring
SKILLS NECESSARY
- Strong communication skills, both written and verbal
- Quality Engineering with analysis tools
- Computer literate
- Organized file management
- Management and/or interaction with multilevel staff
EXPERIENCE LEVEL
5-10 years in a pharmaceutical/medical device quality management/regulatory affairs position. Minimum BS Science or Management or equivalent experience in quality assurance positions.
