Quality Inspector
About The Position
Corin is seeking a Quality Inspector to carefully check joint implants and instruments to ensure they meet regulatory agency guidelines, department procedures, and product specifications. The Quality Inspector will join our quality team in Raynham, MA on a full time basis. The inspection process includes paperwork verification, visual inspection and mechanical inspection. The key responsibilities of the Quality Inspector are/to: Complete paperwork related to inspections - such as lot/traveller records, device history records, inspection records, and non-conforming material report forms - to ensure information is accurate and compliant to internal procedures and quality standard regulations. Assist on or perform first article activities for new product or for vendor changes to existing product. Initiate Non-Conforming Material Reports (NCMRs) and assist in related inspections and dispositions. Assist in the control and maintenance of documents associated with Quality activities (e.g. calibration, CAPAs, NCMRs). Assist in data collection and analysis for ongoing quality improvements. Conduct periodic inventory cycle counts in the Quality Inspection Area. Conduct spot checks of the quality record files to ensure integrity of files. Perform special request inspections and rework projects as required. Assist in the creation of department procedures and changes to documents. Record data in relevant databases and spreadsheets. Define problems, collect data, establish facts, and draw valid conclusions. Must be able to prioritize tasks and determine important criteria when solving problems Have a general knowledge of orthopedic products. Have a general knowledge of Quality systems for medical devices which includes 21 CFR 820, 21 CFR 11, EN ISO 13485, Directive 93/42/EEC) as related to requirements directly applicable to acceptance activities
Requirements
- A High School Diploma or equivalent
- Work history of successfully collaborating as part of a team
- Experience in FDA and ISO regulated environments
- Familiarity with Document Release and Change Control Process
- Experience of writing submission documents that conform to a prescribed style and format of government regulatory agencies
- Demonstrated the ability to analyse, and interpret common scientific and technical journals, US and international regulations and legal documents
- Demonstrated the ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
- Used database software, MS Office (Excel, Word)
- Knowledge of SAGE Software ideally
Nice To Haves
- A Quality Technician Certification (CQT) and/or ASQ certification and/or Six Sigma training would be advantageous
Responsibilities
- Complete paperwork related to inspections - such as lot/traveller records, device history records, inspection records, and non-conforming material report forms - to ensure information is accurate and compliant to internal procedures and quality standard regulations.
- Assist on or perform first article activities for new product or for vendor changes to existing product.
- Initiate Non-Conforming Material Reports (NCMRs) and assist in related inspections and dispositions.
- Assist in the control and maintenance of documents associated with Quality activities (e.g. calibration, CAPAs, NCMRs).
- Assist in data collection and analysis for ongoing quality improvements.
- Conduct periodic inventory cycle counts in the Quality Inspection Area.
- Conduct spot checks of the quality record files to ensure integrity of files.
- Perform special request inspections and rework projects as required.
- Assist in the creation of department procedures and changes to documents.
- Record data in relevant databases and spreadsheets.
- Define problems, collect data, establish facts, and draw valid conclusions.
- Must be able to prioritize tasks and determine important criteria when solving problems
- Have a general knowledge of orthopedic products.
- Have a general knowledge of Quality systems for medical devices which includes 21 CFR 820, 21 CFR 11, EN ISO 13485, Directive 93/42/EEC) as related to requirements directly applicable to acceptance activities
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
101-250 employees
