Quality System Engineer II

Resonetics•Nashua, NH

6d•$65,000 - $102,000

About The Position

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger. The Quality Systems Engineer II is responsible for the development, maintenance, and continuous improvement of the Quality Management System (QMS) in a regulated medical device manufacturing environment. This role ensures compliance with applicable regulatory and quality standards (e.g., ISO 13485, FDA QMSR,) while supporting operational excellence across multiple sites.The position partners cross-functionally to strengthen quality systems infrastructure, support audits and inspections, drive corrective action effectiveness, and enhance quality system performance using risk-based and data-driven approaches. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

Minimum 3 years' experience in a Quality Systems role.
Bachelor’s degree in engineering, science, or a related technical discipline, or equivalent experience.
Demonstrated experience working within an ISO 13485 and/or FDA-regulated Quality Management System.
Strong written and verbal communication skills, including technical documentation.
Ability to work cross-functionally in a manufacturing or contract manufacturing environment.

Nice To Haves

Experience with electronic Quality Management Systems (e.g., QCBD, ETQ, or equivalent).
Certified Lead Auditor and/or ASQ certification (CQE, CQA, CMQ/OE).
Medical device industry experience.
Lean Six Sigma or continuous improvement training.
Experience supporting multi-site or global quality systems.

Responsibilities

Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and other applicable regulatory requirements.
Develop, revise, review, and approve quality documentation, including policies, procedures, work instructions, records, and product and process validation documentation, to ensure compliance with internal procedures, applicable regulatory requirements, and Quality Management System standards.
Perform and support software validation activities for critical business systems impacting the QMS (e.g., eQMS, complaint handling, CAPA, document control, training, supplier management), in accordance with applicable regulatory and internal validation requirements.
Plan, perform, and support internal and supplier audits, including audit preparation, execution, documentation of results, and follow-up of corrective actions.
Facilitate and support customer and regulatory audits, including audit preparation, response development, and follow-up activities.
Partner cross-functionally to investigate nonconformances, customer complaints, and audit findings; drive timely and effective corrective and preventive actions (CAPA).
Monitor critical quality system sub-systems to ensure activities are completed in a compliant and timely manner (e.g., complaints, nonconforming material reports/NCRs, customer documentation requests).
Serve as a quality systems liaison with internal stakeholders and external customers for quality system–related matters.
Develop and deliver training on quality system requirements, procedures, and best practices to ensure organizational compliance and quality awareness.
Analyze quality system performance metrics and trends; communicate results and risks to management and drive continuous improvement initiatives.