QC Inspector II

TransMedics, Inc.; Andover (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a QC Inspector II to ensure product quality through detailed inspections and compliance with company policies. The ideal candidate will have experience in quality control within medical device manufacturing and strong communication skills. Join a team that values continuous improvement and quality assurance in a dynamic environment.

Qualifications

• 3+ years of Quality Control experience in Medical Device Manufacturing.
• Knowledge of clean room operations and cGMP required.

Responsibilities

• Perform visual and dimensional inspection of products.
• Conduct batch record review and release.
• Communicate non-conformances and generate reports.

Skills

Quality Control

Communication

Teamwork

Attention to Detail

Education

High School Diploma

Tools

Inspection Tools

Microsoft Word

Microsoft Excel

Access

Job description

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• With minimal supervision, performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
• Conducts batch record review and release, including review of NCMR’s, deviations etc.,
• Interprets route tickets, quality inspection documents, and drawings to decipher quality requirements for the product.
• 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
• Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications. Reports and generates material nonconformance reports (NCMR’s) and enters into Access database.
• Recommends activities to promote continuous improvement and best practices
• Performs other TransMedics tasks and duties as required
  
  

Job Description

ESSENTIAL TASKS AND DUTIES INCLUDE:

• With minimal supervision, performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
• Conducts batch record review and release, including review of NCMR’s, deviations etc.,
• Interprets route tickets, quality inspection documents, and drawings to decipher quality requirements for the product.
• 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
• Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications. Reports and generates material nonconformance reports (NCMR’s) and enters into Access database.
• Recommends activities to promote continuous improvement and best practices
• Performs other TransMedics tasks and duties as required
  
  

Background And Qualifications

• 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations a plus
• Understanding of cGMP and GDP required
• Demonstrated ability to read and write English with ability to follow written instructions or procedures. Strong verbal and written communication skills.
• 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.
• Team oriented with demonstrated interpersonal skills and positive attitude
• Ability to independently manage time efficiently.
• Ability to read, interpret, and understand drawings and specifications.
• Detail oriented and follows instructions and specifications meticulously.
• Working knowledge of Miscrosoft Word, and Outlook required. Knowledge of Microsoft Excel, Access, Powerpoint a plus.
  
  

Education

• High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience
  
  

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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