Quality Engineer - Raynham
About The Position
Corin is seeking a proactive, detail-oriented Quality Engineer based in Raynham, Massachusetts, to provide quality leadership and support across its operations. The role ensures compliance with customer requirements, regulatory standards, and internal quality objectives. It helps drive continuous improvement, reduce quality costs, maintain compliance with FDA and ISO standards, and support the organization's commitments to Safety, Quality, Customer Satisfaction, and Innovation. The Quality Engineer works with cross-functional teams to strengthen quality systems, support audits, investigate quality issues, and ensure effective quality processes. The position focuses on quality engineering practices, quality assurance specifications and testing, CAPA, calibration systems, regulatory compliance, non-conformance management, and guidance for QC Technicians.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related discipline, or an equivalent combination of education and experience.
- Strong working knowledge of medical device quality systems and regulatory requirements.
- Experience with FDA 21 CFR Part 820, FDA 21 CFR Part 11, EN ISO 13485, MDSAP, and Medical Device Directive 93/42/EEC.
- Experience supporting CAPA, audit programmes, calibration systems, and non-conformance management.
- Working knowledge of supplier quality, product development, validation, and quality engineering principles.
- Strong analytical and problem-solving skills, including the ability to identify root causes and implement effective solutions.
- Understanding of GD&T, calibration methodologies, and inspection processes.
- Ability to interpret technical instructions, engineering drawings, and complex data sets.
- Excellent interpersonal and communication skills, with the ability to build effective working relationships across organizational levels and with suppliers and customers.
- Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
- Advanced Microsoft Office skills, particularly in Excel, and experience working with quality databases and systems.
Nice To Haves
- Quality engineering experience in a regulated manufacturing environment, ideally medical devices.
- Medical device quality systems and regulatory experience within the orthopaedic sector.
Responsibilities
- Investigate, identify, and implement best-in-class Quality Engineering practices.
- Develop quality assurance specifications, test methods, sampling plans, and associated procedures.
- Support CAPA activities, including investigations, root cause analysis, corrective actions, and effectiveness checks, to ensure timely closure.
- Maintain and support the equipment calibration programme, including scheduling, record reviews, out-of-tolerance investigations, and audit support.
- Ensure compliance with ISO 13485 and MDSAP requirements related to calibration activities.
- Prepare for and support internal and external audits by coordinating evidence collection, supporting auditor interviews, and facilitating corrective action responses.
- Apply structured problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Support non-conforming material processes and participate in MRB meetings to resolve product and process non-conformances.
- Provide technical guidance to QC Technicians regarding inspection activities.
- Lead initiatives to improve product quality, reduce costs, and increase operational efficiency.
- Ensure compliance with quality system procedures across all areas of responsibility.
Benefits
- Variable compensation package.
- Employee referral program with incentives for each successful hire recommended.
- Professional development and career growth opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
