Quality Inspector II -Cleanroom, 1st Shift
Inspect incoming medical-device components and assemblies for quality, using visual and dimensional checks, documentation review, and calibrated tools during first-shift hours in a regulated manufacturing environment.
- Compensation
- $28–$35 / hr
- Location
- Andover, MA
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 1+ years
- Category
- Manufacturing
- Posted
Skills
Must have
- 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.
Nice to have
- 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.
Full 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.