Senior Quality Management Professional
hace 7 horas
We are seeking an experienced Senior Quality Management Professional to join our team at Ch01 Che Fresenius Medical Care (Schweiz) Ag. This is a dynamic opportunity for a skilled quality expert to drive excellence in quality management, ensuring compliance with regulatory requirements and industry standards.
Responsibilities- Lead the development, implementation, and maintenance of the Company's Quality System and applicable certifications, including ISO 13485-2016 and MDSAP.
- Direct the administration of quality policies, procedures, methodologies, and tools, ensuring compliance with product specifications and quality system requirements.
- Act as the primary representative and contact on quality issues at the plant level with Corporate (USA) and sister plants (Italy/Germany).
- Coordinate preparation activities for External Audits at the company's manufacturing sites.
- Report to senior management on the performance of the Quality System and coordinate the preparation of meetings and quality reports for the review of key performance indicators.
To be successful in this role, you will need:
- Minimum of 7 years in Quality, preferably in the Medical Industry, including at least 5 years in supervisory roles.
- Senior level: 10 years in the medical industry, with at least 7 years in supervision.
- Bachelor's degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related field. Master's degree or specialization in engineering and/or Quality Systems is preferred.
- Advanced knowledge of medical industry regulations and standards (ISO 13485-2016, MDSAP, FDA QSRs, EU MDR, CANADA, NOM-241).
- Proficiency in Quality Management and Administration Tools, Risk Management in Medical Devices (e.g., ISO 14971), and application of continuous improvement tools such as Lean Manufacturing / Six Sigma.
- Certified Quality Manager by the American Society for Quality (ASQ) is a plus.
The salary for this position is estimated to be around $120,000 per year, based on industry standards and location. In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, retirement plan, and opportunities for professional growth and development.
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