SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

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

• Work Experience: 8+ years of experience in a regulated industry
• Industry Knowledge: experience in Engineering, Life Science, or a related technical is required
• Stakeholder management: Ability to drive forward the commercial agenda by managing stakeholder groups from diverse cultural backgrounds, internal and external audiences, and varying levels of seniority. Demonstrated ability to lead, motivate, and influence others.
• Leadership ability: Excellent aptitude for leading, inspiring, and collaborating with cross-functional teams.
• Language: Fluent in English & German

Preferred Qualifications

• Education: Bachelor’s degree in life science or Engineering
• Qualified Lead auditor to ISO 13485
• You enjoy working with people from different departments, cultures, and hierarchy levels

We Offer

• An exciting opportunity in a fast-growing international medical device company
• A modern working environment, with multicultural and dynamic teams
• Flexible working hours and a hybrid remote work policy
• A centrally located office in Zug, very close to the train station

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department.

Please note: For this position, we do not consider applications from recruitment agencies.

For more information on SHL Medical, please visit: shl-medical.