Careers – Quality Manager
Essential Functions & Responsibilities (Other Functions May Be Assigned)
- Maintains 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.· Maintains and enhances processes to ensure quality system compliance with the FDA Quality System Regulation (21 CFR Part 820, Part 803, Part 11).
- ISO Management Representative and MDR Qualified Person.
- Oversees the scheduling, performance and responses to internal and external audits.
- Manages the company CAPA system.
- Supports Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product.
- Leads Management Review meetings.
- Oversees, maintains, and creates Quality System documentation and regulatory files.
- Participates in decision-making team relating to Medical Device Vigilance, MDR’s, product recalls and issuance of Advisory Notices, if required.
- Reviews and approves validation activities.
- Leads Incoming Inspection, Document Control and Supplier Quality functions.
Qualifications / Experience Requirements
- 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.
- 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.
- Excellent communication, interpersonal, time management, and leadership skills.
- Must have a “how can we get it done,” rather than a “why we can’t do it” approach.
- We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
- Appropriate quality certifications preferred.
- Required education: Bachelor's in Engineering.
If you are interested in this position at Exergen Corporation, please fill out the form below and we'll get back to you.
Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.
Our Temporal Scanner™ is the most efficacious, non-invasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 12 million consumers use one at home.
Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.