A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Quality Control Inspector Roeg Wilmington, MA Job Details Temp-to-hire $26 - $30 an hour 1 day ago Qualifications Teamwork High school diploma or GED Attention to detail Data collection
ISO 13485
Full Job Description
POSITION SUMMARY
The desired candidate will have prior Quality Inspector experience, preferably working in a medical device company. Specific experience and responsibilities will include, but not be limited to, performing incoming mechanical inspections, various functional testing, final inspections, and support of calibration and equipment programs.
ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES
Perform incoming mechanical inspection on a variety of medical devices including custom needle assemblies, stainless steel surgical instruments, scalpel blades, glass LOR syringes, trocars, etc. Interpret engineering drawings and blueprints to determine inspection points and required product specifications. Use a variety of instruments for visual, dimensional, functional, and destructive testing (micrometer, caliper, video measuring equipment, Lloyd materials tester, pin gages, etc.) Conduct a variety of functional testing i.e. (pull, peel, burst, penetration) Generate Certificates of Conformance for accepted material prior to release of product Perform final inspection on packaged material ready to be shipped by confirming shipping documentation and product labeling. Release material from Pending QA Inspection location to packaging area once the material has been inspected, accepted, and a COC has been generated. Support the calibration program Support equipment PM program Support the temperature logging program with data collection and review of information
MINIMUM REQUIREMENTS
High School Diploma or equivalent 2+ yrs. in a similar quality inspection role
PREFERRED SKILLSET
Prior medical device experience a plus Knowledge of FDA Quality System requirements and
ISO 13485
requirements a plus Excellent organizational, verbal, written communication, and problem-solving skills. Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner. Ability to work in a fast-paced environment and to meet tight deadlines. Willingness to learn, possess a can-do attitude, and motivated to succeed and grow. Ability to multi-task with strong attention to detail Proficient in
MS Office Suite, and of Statistical Process Control Practices Pay:
