Our client, a designer and manufacturer of infrared scanners, thermometers, and sensors, has an immediate opening for a Quality Manager.
- Maintain the compliance status of the company with respect to quality system certifications to ISO 13485:2016, MDSAP, EN ISO 13485:2012, Canadian Requirements, and Medical Device Directive Annex II. Maintain and enhance processes to ensure quality system compliance with the FDA Quality System Regulation (21 CFR Part 820, Part 803, Part 11).
- Oversee the scheduling, performance, and responses to internal and external audits
- Manage the company CAPA system
- Support Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product
- Lead Management Review meetings
- Lead Incoming Inspection, Document Control, and Supplier Quality functions
- Bachelor's in Engineering
- Minimum of 3-5 years as a manager of QA/RA at a medical manufacturing company with an appreciation for the requirement of meeting customer delivery requirements
- ISO Management Representative and MDR Qualified Person
- Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device Regulations. Other countries may become necessary.
- Experience with devices containing both hardware and software components
- Experience with 21 CFR Part 11 Electronic Systems preferred
- Must have a problem-solving attitude
- Appropriate quality certifications preferred