Quality Systems Engineer - medical device

InnoTech Staffing•Manchester, NH

5d•Onsite

About The Position

InnoTECH Staffing is hiring an onsite Quality Systems Engineer in Manchester, New Hampshire. The role contributes to quality and regulatory compliance in a collaborative, cross-functional environment. The engineer owns and manages the end-to-end CAPA process, including intake, triage, investigation, root cause analysis, corrective and preventive action planning, and effectiveness verification. The role also develops and revises SOPs and associated change controls, maintains QMS compliance, reviews quality records, conducts internal audits, and supports external audits. Additional responsibilities include monitoring CAPA trends, supporting continuous improvement, and training and mentoring team members on CAPA practices and root cause analysis.

Requirements

BS/MS in Engineering, Life Sciences, or a related field.
At least 3 years of experience in a quality systems role in a regulated industry, ideally medical devices.
Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
Proficiency with Microsoft Excel, Word, and Visio, or ability to learn quickly.
Strong verbal and written communication skills.
Experience in project coordination and technical writing.
Strong attention to detail.
Ability to communicate complex concepts clearly to diverse audiences and across technical backgrounds.
Curiosity and ability to quickly grasp technical systems, workflows, and requirements.
Organization, dependability, and follow-through in coordinating projects and meeting deadlines.
Proactive problem-solving skills, including asking questions and challenging assumptions constructively.
Collaborative and constructive approach to working with others.

Responsibilities

Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification.
Facilitate cross-functional CAPA review meetings, helping teams identify systemic issues and agree on remediation strategies.
Ensure CAPAs include objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records.
Maintain CAPA documentation in line with regulatory expectations, ensuring timely closure, audit readiness, and linkage to risk management where applicable.
Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement.
Support training and mentorship of team members on CAPA expectations, best practices, and root cause analysis tools.
Develop and revise SOPs and associated change controls to align with regulatory requirements and support QMS compliance.
Maintain compliance with FDA 21 CFR Part 820 and ISO 13485 and support the integrity and effectiveness of the QMS.
Use knowledge of QMS processes to identify and implement system improvements.
Review and approve quality records for accuracy, completeness, and adherence to applicable requirements.
Conduct internal audits and support auditor training to promote audit readiness and regulatory compliance.
Support external FDA, ISO, and customer audits by preparing documentation, facilitating audit logistics, and responding to auditor requests in real time.