Job Overview

The Senior Quality Operations Manager plays a crucial role in ensuring that products manufactured at SHL Swiss site meet required standards of quality, reliability, and regulatory. This position involves managing the team of QA and QC personnel, establishing, qualifying and managing the operations of QC / QA processes, flow, equipment & tools at manufacturing facility in Zug. This person will be responsible also for quality assurance activities during the product lifecycle and interaction with business partners.

The Senior Quality Operations Manager will lead a team of quality engineers, inspectors and technicians, develop quality control procedures, execute and work collaboratively with other departments.

Main Responsibilities

• Establish and qualify QC Laboratory, equipment, required tests and inspections and ensure their 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 that 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 that 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 that they have the knowledge and skills necessary to perform their jobs effectively.

Minimum requirements

Preferred Qualifications

We Offer