- Responsible for compliance with Quality policies, procedures and international regulations whil also leading improvement activities in line with internal quality system.
- Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
- Preperation of reports for production, enviornmnetal monitoring, vendor assessments, NCRs , CAPAs and supplier corrective actions.
- Deal with quality matters in relation to agencies, vendors and regulators.
- Implemnet, develop and improve quality tools in relation to risk management, risk management, dFMECA, pFMECA and associated reports.
- Assist department and project leaders in developing and reporting appropriate performance and quality metrics.
- Bachelors degree in engineering, science or related field with 5 years or more in QA, QMS or regulatory affairs.
- Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Directive, and the Canadian Medical Device Regulations.
If you need any additional information, please feel free to contact email@example.com or call 091455305 for a quick discussion about this role. All applications are treated with the utmost discretion.
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