Quality Inspector II-2nd Shift

TransMedics•Andover, MA

8h•$30 - $30

About The Position

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 11:00PM. RESPONSIBILITIES This position is responsible for, but not limited to, the following: With minimal supervision, 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). Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications. Conducts batch record review and release, including review of NCMR’s, deviations etc. Recommends activities to promote continuous improvement and best practices. 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 High School Diploma 3+ years of Quality Control Experience in Medical Device Manufacturing. OR Equivalent job experience with additional training in the trade; or equivalent combination of education and experience Understanding of a quality management system (QMS) and cGMP knowledge PREFERRED QUALIFICATIONS 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. 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. Every Organ Wasted is a Life Not Saved. 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 compensation for this role is a fixed rate of $30.00 (hourly), based on our good-faith determination. Actual compensation is non-negotiable and not subject to variation. 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.

Requirements

High School Diploma
3+ years of Quality Control Experience in Medical Device Manufacturing.
OR Equivalent job experience with additional training in the trade; or equivalent combination of education and experience
Understanding of a quality management system (QMS) and cGMP knowledge
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

Nice To Haves

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.
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.

Responsibilities

With minimal supervision, 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).
Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications.
Conducts batch record review and release, including review of NCMR’s, deviations etc.
Recommends activities to promote continuous improvement and best practices.
Perform other TransMedics tasks and duties as assigned/required.