Quality Inspector

Responsibilities:

• Perform incoming inspection of materials and receiving documentation for conformity to specifications.
• Support manufacturing operations through timely review of DHR’s including release of finished goods.
• Adhere to good manufacturing practices and good documentation practices.
• Assist Quality Engineers and manufacturing personnel in the execution of calibration activities including review and retrieval of calibrated equipment for processing.
• Positive and cooperative communication and collaboration with all levels of employees, contractors and vendors.
• Assist in both internal and external audit preparation.
• Participate in NCMRs / CAPA’s to better improve company practices and systems.
• Perform quarterly Air Sampling / Particle Testing in the Clean Room.
• Other duties as assigned.

Location: Marlborough, MA

Qualifications

• Requirements:
• High School Diploma or equivalent is required.
• Additional training in Quality and/or a focus in medical device preferred.
• 1-3 years of experience in a Quality role (medical device preferred, other regulated industries considered).
• Strong working knowledge of Microsoft Word and Excel.
• Understanding of ISO 13485, ISO 14644, and CFR 21-820.
• User experience of QMS, PLM and CMMS systems.
• Organizational skills and attention to detail.
• Ability to read drawings and prints.