Quality Control Supervisor

POSITION SUMMARY:

This position will support the planning and implementation of clinical studies and the associated medical device training and operation for This position will participate in the implementation and maintaining of cGMP/QSR (21 CFR 820) and ISO 13485 quality systems, quality and materials control activities of PulseTx System, DermaPulseTx System, single-use Applicators and reusable medical devices in support of the Company’s research and development, quality, manufacturing, regulatory, and clinical efforts. In addition, this position will support the development and implementation of medical device Class II, III quality systems and compliance activities.

DESCRIPTION:

QUALIFICATIONS/REQUIREMENTS:

This position requires 10+ yrs medical device experience and an AA/ AS degree in science, technology or equivalent.  Mastered the use of quality control disciplines, tools, and analyzing methodologies. Must have good communication and time management skills. Working experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements are required. Must also have working knowledge and experience in the following areas: Quality Control, Materials Control, Change Control (ECO), Non-Conforming, CAPA, Sterilization, Packaging, Shelf Life Validation, and general Quality Systems compliance. Preferred experience working with complex energy-based medical electrical systems and products such as high frequency RF, Laser, Ultrasound, Microwave or Cryosurgery, etc.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

CONTACT:

Send resume to: Careers@pulsebiosciences.com