Job Overview
Employment Type
Full-time
Compensation
Hourly
Range $23.00 - $26.00
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Paid holidays
Professional Development
Employee assistance program
Job Description
Corin is a reputed medical device company specializing in the development and manufacturing of orthopedic joint implants and surgical instruments. Headquartered in Raynham, Massachusetts, Corin is dedicated to improving patient outcomes by delivering innovative and high-quality orthopedic solutions to healthcare providers around the world. The company operates with a strong commitment to quality, regulatory compliance, and continuous improvement, employing state-of-the-art manufacturing processes and adhering to stringent quality standards. Corin continues to grow in the competitive medical device field, offering a collaborative work environment where employees are encouraged to contribute their expertise and develop professionally.
The role of the Quality Inspector at Corin is vital in maintaining the company’s standards of excellence. This full-time position based at the Raynham facility focuses on inspecting joint implants and instruments to ensure they comply with regulatory agency guidelines, internal department procedures, and detailed product specifications. The Quality Inspector’s responsibilities span completing precise paperwork verification, conducting thorough visual inspections, and performing mechanical inspections to evaluate the quality and safety of products before they reach the market.
The position requires an individual who is meticulous, knowledgeable in quality systems related to medical devices, and skilled in regulatory standards such as 21 CFR 820, 21 CFR 11, EN ISO 13485, and Directive 93/42/EEC. The Quality Inspector will be instrumental in activities ranging from first article inspections for new products or vendor changes, to initiating and supporting Non-Conforming Material Reports (NCMRs), conducting inventory cycle counts, and assisting with document control related to quality activities including calibration and CAPAs.
Candidates who excel in this role are detail-oriented and demonstrate strong analytical skills. They will use their expertise to collect and analyze data to drive continuous quality improvements and support compliance by ensuring integrity in quality documentation and inspection records. They will also contribute to special request inspections and rework projects, playing a key role in upholding the company’s reputation for quality and regulatory compliance.
The ideal candidate will have prior experience working in FDA and ISO regulated environments, possess knowledge of orthopedic products, and be familiar with document release and change control processes. Additional qualifications such as a Certified Quality Technician (CQT), ASQ certification, or Six Sigma training will be beneficial. Proficiency in Microsoft Office and experience with database software is expected, with knowledge of SAGE software considered a plus.
The position offers a competitive base pay range of $23 to $26 per hour, with specific compensation influenced by the candidate’s experience, education, and skill set. Corin fosters a diverse and inclusive workplace, providing equal employment opportunities without discrimination based on race, color, religion, age, sex, national origin, disability, genetics, veteran status, sexual orientation, gender identity, or any other protected characteristic under federal, state, or local laws.
Joining Corin as a Quality Inspector means becoming part of a team dedicated to advancing orthopedic healthcare through innovation and uncompromising quality. The role offers the opportunity to develop professionally within a respected medical device company committed to patient safety and regulatory excellence.
The role of the Quality Inspector at Corin is vital in maintaining the company’s standards of excellence. This full-time position based at the Raynham facility focuses on inspecting joint implants and instruments to ensure they comply with regulatory agency guidelines, internal department procedures, and detailed product specifications. The Quality Inspector’s responsibilities span completing precise paperwork verification, conducting thorough visual inspections, and performing mechanical inspections to evaluate the quality and safety of products before they reach the market.
The position requires an individual who is meticulous, knowledgeable in quality systems related to medical devices, and skilled in regulatory standards such as 21 CFR 820, 21 CFR 11, EN ISO 13485, and Directive 93/42/EEC. The Quality Inspector will be instrumental in activities ranging from first article inspections for new products or vendor changes, to initiating and supporting Non-Conforming Material Reports (NCMRs), conducting inventory cycle counts, and assisting with document control related to quality activities including calibration and CAPAs.
Candidates who excel in this role are detail-oriented and demonstrate strong analytical skills. They will use their expertise to collect and analyze data to drive continuous quality improvements and support compliance by ensuring integrity in quality documentation and inspection records. They will also contribute to special request inspections and rework projects, playing a key role in upholding the company’s reputation for quality and regulatory compliance.
The ideal candidate will have prior experience working in FDA and ISO regulated environments, possess knowledge of orthopedic products, and be familiar with document release and change control processes. Additional qualifications such as a Certified Quality Technician (CQT), ASQ certification, or Six Sigma training will be beneficial. Proficiency in Microsoft Office and experience with database software is expected, with knowledge of SAGE software considered a plus.
The position offers a competitive base pay range of $23 to $26 per hour, with specific compensation influenced by the candidate’s experience, education, and skill set. Corin fosters a diverse and inclusive workplace, providing equal employment opportunities without discrimination based on race, color, religion, age, sex, national origin, disability, genetics, veteran status, sexual orientation, gender identity, or any other protected characteristic under federal, state, or local laws.
Joining Corin as a Quality Inspector means becoming part of a team dedicated to advancing orthopedic healthcare through innovation and uncompromising quality. The role offers the opportunity to develop professionally within a respected medical device company committed to patient safety and regulatory excellence.
Job Requirements
- A High School Diploma or equivalent
- Experience in FDA and ISO regulated environments
- Knowledge of orthopedic products
- Familiarity with 21 CFR 820, 21 CFR 11, EN ISO 13485, Directive 93/42/EEC
- Ability to perform detailed mechanical and visual inspections
- Proficiency in MS Office and database software
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and manage multiple responsibilities
- Excellent communication skills
- Attention to detail and accuracy
Job Qualifications
- A High School Diploma or equivalent
- Quality Technician Certification (CQT) or ASQ certification or Six Sigma training preferred
- Experience working in FDA and ISO regulated environments
- Familiarity with document release and change control processes
- Experience writing submission documents conforming to regulatory agency styles and formats
- Ability to analyze and interpret scientific and technical journals, US and international regulations, and legal documents
- Ability to apply mathematical operations including frequency distribution, test reliability, analysis of variance, correlation techniques, sampling theory, and factor analysis
- Experience using database software and MS Office (Excel, Word)
- Knowledge of SAGE Software is advantageous
- Demonstrated ability to collaborate effectively as part of a team
Job Duties
- Complete paperwork related to inspections such as lot/traveller records, device history records, inspection records, and non-conforming material report forms
- Assist on or perform first article activities for new product or vendor changes
- 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 including 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 creation of department procedures and document changes
- Record data in relevant databases and spreadsheets
- Define problems, collect data, establish facts, and draw valid conclusions
- Have a general knowledge of orthopedic products
- Have a general knowledge of quality systems for medical devices including 21 CFR 820, 21 CFR 11, EN ISO 13485, Directive 93/42/EEC as related to acceptance activities
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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