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Senior Quality Operations Director
vor 1 Monat
The Senior Quality Operations Manager plays a pivotal role in ensuring products manufactured at SHL Swiss sites meet quality, reliability, and regulatory standards.
This position involves managing QA and QC personnel, establishing, qualifying, and managing QC/QA processes, flow, equipment, and tools at the manufacturing facility in Zug.
Main Responsibilities:- Establish and qualify QC Laboratory, equipment, required tests, and inspections to ensure operability.
- Manage and maintain QC Laboratory and its systems in readiness and validity.
- Ensure regulatory and contractual compliance following applicable standards including FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), and other national and international regulations and standards.
- Develop and implement quality control processes, procedures, and policies to ensure products or services meet or exceed customer expectations.
- Monitor and analyze data related to quality control processes and quality production data, identifying trends, and making recommendations for improvement.
- Lead and manage a team of quality control and assurance personnel, providing guidance, coaching, and support as needed.
- Communicate with other teams, departments, and stakeholders to ensure quality operations processes are aligned with business objectives.
- Perform regular audits of quality operations processes, identifying areas for improvement and making recommendations for corrective action.
- Provide leadership for preparation and execution of external parties inspections, audits, ISO certification, and customer audits.
- Manage and maintain quality control and assurance documentation, ensuring that all necessary records are accurate and up-to-date.
- Train team members on quality control processes, procedures, and policies, ensuring they have the knowledge and skills necessary to perform their jobs effectively.
