Quality Inspector II - Cleanroom, 1st Shift
TransMedics, Inc.
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.
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
- 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.
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.
Requirements
- 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
- Prior experience working in clean room environments (preferred)
- Excellent verbal and written communication skills (preferred)
- Strong math skills including measuring dimensions using calibrated tools, and calculating specifications (preferred)
- Knowledge of Microsoft Excel, Access, Powerpoint a plus (preferred)
- Ability to work overtime hours, or support weekend operations a plus (preferred)
Benefits
- Medical, Dental & Vision
- Health Reimbursement Account
- Healthcare Flexible Spending Account
- Dependent Care Flexible Spending Account
- Short Term Disability
- Long Term Disability
- 401(k) Plan
- Pet Insurance
- Employee Stock Purchase Plan
- Paid Time Off
Company overview
TransMedics, Inc. is a commercial-stage medical technology company revolutionizing organ transplant therapy for patients worldwide. Founded in 1998 and headquartered in Andover, Massachusetts, the company has developed the innovative Organ Care System (OCS™) technology platform that transforms organ preservation from static cold storage to dynamic perfusion systems. The OCS is the only FDA-approved technology for lung, heart, and liver transplant indications in the United States, enabling the optimization and assessment of donor organs outside the human body. This groundbreaking technology replicates near-physiologic conditions where the lung breathes, the heart beats, and the liver produces bile while being transported. TransMedics operates the National OCS Program (NOP), featuring a nationwide team of clinical experts, 24/7 logistics support, and a dedicated air and ground transport network. The company's mission focuses on increasing access to viable donor organs for transplant patients, addressing the critical shortage of transplantable organs. With over 25 years of commitment to innovation, TransMedics has established itself as a leader in advancing the field of organ transplantation through its comprehensive technology platform and clinical expertise.