Quality Engineer

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 the Design & Development projects as responsible for design assurance activities across all project phases ensuring 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 to assure 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.

To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.

To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.

To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.

To utilize Quality Engineering best practices, ensuring internal and external customers' needs and requirements are built into new products and future product changes.

To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.

To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.

To 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.

To develop quality plans and work further with Manufacturing on the transfer of quality requirements.

To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering

Fluent in written and spoken English.

Experience from working with 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 application of Quality Methodologies such as DFSS, DMAIC, 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 in 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