Resonetics · 9 hours ago
Quality System Engineer II
Dayton, OH
Full-time
Hybrid
Mid Level
$65K/yr - $102K/yr
3+ years expResonetics is a global leader in advanced engineering and micro manufacturing within the medical device industry. The Quality Systems Engineer II is responsible for developing and maintaining the Quality Management System (QMS) to ensure compliance with regulatory standards while supporting operational excellence across multiple sites.
Life ScienceManufacturingMedical Device
No H1B
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
Qualification
Required
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
Preferred
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
Company
Resonetics
Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Carlyle GroupRegatta Medical
2021-12-03Private Equity· $1.12B
2018-02-01Private Equity
2014-10-22Acquired
Leadership Team
Todd Trapp
Chief Financial Officer
D
David Rezac
Global Vice President, AGILE Product Development
Recent News
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2025-10-31
Venture Capital
2025-09-30
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