Vacant job

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in Design & Development projects. This role is responsible for design assurance activities across all project phases, ensuring the quality and robustness of the product design and manufacturing processes (including product care projects, design changes, and design reviews).

Furthermore, the Quality representative is responsible for assuring compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• Act as Workstream Lead Quality, applying Quality Engineering principles dynamically in development and production projects.
• Represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• Ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• Support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning (APQP), DFSS, and Risk tools and techniques across all product development phases. Promote the use of statistics in testing and quality control.
• Support and guide Risk Management activities (FMEAs). Assess and approve risk mitigation techniques implemented and verify if these are consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, and product and process controls.
• Support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions and reliability test activities.
• Develop quality plans and work closely with Manufacturing on the transfer of quality requirements.
• Contribute to the compilation and maintenance of Design History Files (DHF).

Minimum Requirements

• Minimum 5+ years of work experience in relevant roles such as Quality Assurance or Quality Engineering.
• Fluent in written and spoken English.
• Experience from working with the interpretation of ISO Standards, e.g., EN ISO 14971:2019 and EN ISO 13485:2016.
• Experience in establishing, reviewing, and approving quality documentation.
• Experience with model development, test method validation, and statistical analysis.
• Green Belt practitioner, or demonstrated experience in the application of Quality Methodologies such as DFSS, DMAIC, or Lean.
• Hands-on experience in product development from ideation to launch in the Medical Device Industry.

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry.
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position.