Quality Inspector I-Incoming Inspection, 1st Shift

POSITION SUMMARY

This position involves ensuring products meet established quality standards and specifications at various points in the organization. Duties include inspection of critical components and other raw goods and assemblies used in Class III medical devices, examining shipments of raw goods and electronic components, and inspecting required traceability documentation. Key responsibilities include visual and dimensional inspection, performing tests to determine product functionality, maintaining records, and collaborating with various teams to improve quality.

This role is for a first shift position, with standard working hours from 7:00AM to 3:30PM.

RESPONSIBILITIES

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

• Perform intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
• Interprets drawings, blueprints, and specifications to determine product acceptability. Approves products/batches by confirming specifications, and conducting visual and measurement tests.
• Select proper AQL samples based on batch sizes, where required.
• Record and reports inspection and testing data.
• Review and interprets supplier documentation, including certificates of analysis or conformance, packing slips, sterilization reports, and other lot traceability documentation.
• Monitor use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately.
• Review products for re-work and confirms conformity to required quality specifications.
• Conduct visual inspection under magnification for printed circuit board assemblies (PCBA), confirming conformity to specifications and IPC standards as required.
• Ensure departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).
• Identify and documents non-conformances to specifications.
• Conduct quality documents and lot traceability 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 lift up to 40 pounds
• Ability to stand for long periods of time
• Ability to use microscopes or other magnification devices for long periods of time             

MINIMUM QUALIFICATIONS                                                         

• 1-3 years of Quality Control Experience in Medical Device Manufacturing Environments. 
• 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 inspection tools such as Tappi Charts, micrometers, height gauges, thread gauges, and Vision System knowledge a plus. 

PREFERRED QUALIFICATIONS

• Excellent verbal and written communication skills.
• Strong math skills including measuring dimensions using calibrated tools, and calculating specifications.
• IPC-610 Certification
• 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.