QC Inspector II; 1st 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 first shift position, with standard working hours from 6am to 2:30pm.

This 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.

This position manages the following positions on a daily basis. This position will not have management responsibilities.

• 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.

• 1-3 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.

• 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.

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision Healthcare
• Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

Trans Medics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

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…