Quality Inspector II - Cleanroom, 1st Shift

TransMedics; Andover (MA); Presencial; USD 34 000 - 48 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

Dental

Vision

401K Plan

Employee Stock Purchase Plan

Paid time off

Resumo da oferta

TransMedics, Inc. is seeking a Quality Control Inspector to perform visual and dimensional inspection of components and final assemblies for Class III medical devices. You will read drawings and procedures, approve in-process and finished products, and ensure compliance with CGMP and GDP.

First shift, 6:00 am to 2:30 pm, on site in Andover, MA. Candidates should have 1–3 years of QC experience, strong measurement skills, and proficiency with MS Word/Outlook.

Qualificações

• 1–3 years of Quality Control experience in Medical Device Manufacturing.
• High School Diploma or equivalent; or related experience with training in the trade.
• Understanding of CGMP and GDP required.
• Intermediate computer knowledge; 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; use of a calculator.
• Knowledge of inspection tools such as rulers and vernier calipers; other inspection tools a plus.

Responsabilidades

• 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 compliance to company policies related to manufacturing, lot control, documentation, and safety
• Identifies and documents non-conformances to specifications
• Conducts batch record review and release, including review of NCMRs and deviations
• Perform other TransMedics tasks and duties as assigned/required

Conhecimentos

Quality control

English proficiency

Math basics

Reading drawings

MS Word/Outlook

Formação académica

High School Diploma or equivalent

Ferramentas

Rulers

Vernier calipers

Descrição da oferta de emprego

Job Description:

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.

RESPONSIBILITIES

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 TransMedics 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 QUALIFICATIONS

• 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.

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, TransMedics 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.

TransMedics, 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 health.

Maximize your potential at TransMedics, Inc.

www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected hourly rate for this role is$24.71-$35.17, which represents the company’s current good‑faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

• 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

TransMedics 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.