Quality Inspector -Cleanroom, 2nd Shift

Position: Quality Inspector I-Cleanroom, 2nd Shift
Job Description:

POSITION SUMMARY Performs inspection of critical components and completed assemblies used in Class III medical devices. Conducts visual and dimensional inspection of sub-assemblies or final system assemblies, during or post manufacturing processes. Interprets manufacturing procedures, drawings, and assembly inspection instructions in approving or rejecting in-process or final assemblies.

This role is for a second shift position, with standard working hours from 2:30PM to 11:00

PMRESPONSIBILITIESThis position is responsible for, but not limited to, the following:

Performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.

Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work Reviews products for re-work and confirms conformity to required quality specifications

Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).Identifies and documents non-conformances to specifications.

Conducts batch record review and release, including review of NCMR’s, deviations etc.

Perform other Trans Medics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES Ability to wear appropriate gowning attire for Clean Room environment (face covering, full length gown, hair covering, gloves, and other required PPE)
Ability to lift up to 40 pounds

Ability to stand for long periods of time

MINIMUM QUALIFICATIONS1-3 years of Quality Control Experience in Medical Device Manufacturing.

High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience

Understanding of CGMP and GDP required

Intermediate computer knowledge required. Working knowledge of Microsoft Word, and Outlook required.

Must be proficient in written and spoken English.

Ability to read, interpret, and understand drawings, blueprints, and specifications.

Must possess intermediate math skills: addition, subtraction, multiplication, division, and efficient use of a calculator.

Knowledge of inspection tools such as rulers and vernier calipers required. Other visual/cosmetic inspection tools such as Tappi Charts a plus.

PREFERRED QUALIFICATIONS Prior experience working in clean room environments.

Excellent verbal and written communication skills.

Strong math skills including measuring dimensions using calibrated tools, and calculating specifications.

Knowledge of Microsoft Excel, Access, Powerpoint a plus.

Ability to work overtime hours, or support weekend operations a plus.

As part of our long-term growth plans, Trans Medics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients.

Specific timing and role impact may vary.

Every Organ Wasted is a Life Not Saved.

Trans Medics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better…