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Adecco is seeking a seasoned Quality Manager to drive continuous improvements and ensure compliance with MDSAP regulations and the Medical Device Regulation (MDR) for a leading medical device company.
Key Responsibilities:- Lead the site quality function, encompassing quality systems, quality engineering, and QC analytical and Microbiology.
- Deliver the Quality Strategy to achieve corporate goals and objectives.
- Ensure compliance with MDSAP regulations and the Medical Device Regulation (MDR).
- Manage the budget for the site quality function.
- Oversee quality deliverables and compliance with design control and validation requirements for new product development.
- Make decisions related to quality issues, conduct root cause analysis, and implement corrective actions to avoid product recalls.
- Review and approve supplier and customer quality agreements to meet compliance and operational requirements.
- Bachelor's degree or equivalent in a scientific discipline or 4+ years of experience in the medical device or pharmaceutical industries.
- Proficient knowledge of applicable Quality System Regulations and ISO quality requirements.
- Familiarity with the Medical Device regulation.
- Strong knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
- Solid understanding of statistical methods, sampling plans, and statistical analysis.
- Experience with analytical methods, equipment, process, software, cleaning, and/or facility/utility validations.
