Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.
Requirements
- 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Four Day Work Week
- Generous Parental Leave
