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Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.
Review and approve quality system documentation, including procedures, work instructions, specifications, and records.
Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.
Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.
Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation.
Now viewing: Quality Assurance
RH
Robert Half
Quality Assurance
Job Description
Benefits:
medicaldental insurancevision care401k planpaid time offResponsibilitiesSupport the development, maintenance, and continuous improvement of quality systems within a regulated medical device environment. This role will be responsible for ensuring compliance with FDA Quality Management System Regulations (QMSR), ISO 13485, and EU Medical Device Regulation (MDR) requirements. Maintain and improve the Quality Management System (QMS) to ensure compliance withFDA QMSR, ISO
13485, and EU MDR requirements.Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.
Review and approve quality system documentation, including procedures, work instructions, specifications, and records.
Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.
Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.
Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation.
Benefits
- Paid Time Off (PTO)
- Dental Insurance
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