Hobbs Medical is a global manufacturer and direct supplier of high-quality accessories for flexible GI and Pulmonary Endoscopy. The Hobbs Medical team is focused on engineering, manufacturing, and delivering the highest quality products to the medical community. We manufacture and supply a full range of standard endoscopy instruments and accessories as well as our highly recognizable niche products. Our expertise and commitment are embodied in the "From our skilled hands to yours" promise and demonstrated in our unmatched product quality performance.

JOB FUNCTION(S):

We are excited to add a Quality Engineer to our team who will lead by example! We are looking for someone to take initiative and ownership to ensure that all products manufactured by Hobbs Medical conform to applicable Quality and Regulatory requirements.

EDUCATIONAL & PROFESSIONAL REQUIREMENTS:

 Minimum requirement: two (2) year degree in engineering or a like science and equivalent experience as a quality professional in a manufacturing setting; preferably medical device

Prior experience with plastics/ injection molding

Familiarity with and ability to interpret regulatory requirements and directives pertaining to medical devices.

Understanding of FDA, Regulatory, and ISO criteria

Excellent written and verbal communication skills.

Ability to write, implement and monitor quality inspection documentation, including quality inspection sheets, procedures, and work instructions

Familiarity with application of statistical techniques and performing measurement system analyses

Experience with performing equipment and process validations

Proficiency with use of inspection tools and methods

Willingness to carry through with other additional duties as assigned

Needs to be able to lift, pull or push up to 25 lbs (parts, bins, etc)

RESPONSIBILITIES:

Serve as a functional lead of the Quality Control department

Assist with inspection of components/products, as necessary

Train QC staff in inspection techniques

Work with Operations and Engineering to develop and implement more robust inspection methods, both in-process and final.

Work as part of team in developing inspection criteria for new products

Leading and assisting on internal, customer, and supplier corrective actions

Works with customers and suppliers on quality issues. Submit deviation requests to customers

Work with engineering to determine process controls including gaging requirements. ·

Works with the Production/Shop Floor management personnel on quality issues and corrective actions.

Assist production by providing specification review and implementation to assure process integrity.

Take the lead on formalizing our design control records by ensuring that we have proper supporting documents such as: Control plans, DFMEA, PFMEA, IQ, OQ, PQ, and any other relative documentation

Assist with other Inspection Department functions as required

OTHER DUTIES:

Follow established safety procedures—Ref. Hobbs Hazard Communication & Lock/Out Tag Out Program policies

Attend seminars and workshops relevant to job responsibilities

Participate in Company meetings and functions, as requested

Assist in other departments when called upon to do so

Complete other duties as required or requested