Quality System Engineer II
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Job Location:
Dayton, TX - USA
Monthly Salary:
$ 65000 - 102000
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
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 thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed love to hear from you.
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 systemrelated 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.
Required Qualifications
- Minimum 3 years experience in a Quality Systems role.
- Bachelors 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 Qualifications
- 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.
Physical Demands
- Primarily office-based work; occasional manufacturing floor presence.
- Up to 1525% travel.
Compensation
- The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65000$102000.
- For temp temp-to-hire and regular full-time positions our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.
Required Experience:
IC
Key Skills
- VMware
- System Design
- Computer Networking
- PowerShell
- Microsoft Windows Server
- Windows
- Systems Engineering
- AWS
- Requirements Management
- Linux
- SAN
- Dns
About Company
We understand the fast-paced medical device development process and the importance of time-to-market. Let us help bring your breakthrough medical devices and diagnostics to market faster.
