Quality Engineer - Raynham

Corin•Raynham, MA

22d

About The Position

The Quality Engineer provides quality leadership and support across operations, ensuring compliance with customer requirements, regulatory standards, and internal quality objectives. The role drives continuous improvement, reduces quality costs, maintains compliance with FDA and ISO standards, and supports 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 quality processes are effective. The role includes developing quality assurance specifications, test methods, sampling plans, and procedures; supporting CAPA and non-conformance activities; maintaining equipment calibration processes; and preparing for and supporting internal and external audits. The Quality Engineer also provides technical guidance to QC Technicians and leads initiatives to improve product quality, reduce costs, and increase operational efficiency. The position is based in Raynham, Massachusetts.

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, preferably in the orthopaedic sector.
Experience with FDA 21 CFR Part 820, FDA 21 CFR Part 11, EN ISO 13485, the Medical Device Single Audit Program (MDSAP), and Medical Device Directive 93/42/EEC.
Experience supporting CAPA, audit programs, 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 identifying root causes and implementing 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 working relationships across organizational levels and with suppliers and customers.
Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
Advanced Microsoft Office skills, particularly Excel, and experience working with quality databases and systems.

Responsibilities

Investigate, identify, and implement best-in-class Quality Engineering practices.
Develop quality assurance specifications, test methods, sampling plans, and associated procedures.
Support CAPA investigations, root cause analysis, corrective actions, effectiveness checks, and timely closure.
Maintain and support the equipment calibration program, 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.
Use structured problem-solving methods 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 areas of responsibility.