Senior Quality Engineer Design

vor 4 Wochen

Zug, Schweiz SHL Group Vollzeit

Job Overview

The Quality Engineer is responsible for the effectiveness and quality of product design and process developments, ensuring compliance with applicable regulations. Quality Engineer supports risk management activities for medical devices and the device part of drug/device combination products, ensures that products are of high quality and directs product development decisions by promoting a Risk-Based approach. Applies Quality Engineering tools, techniques, and methodologies to product development according to the company’s needs and applicable regulations. The job holder is directly involved in establishing and applying efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.

Main Responsibilities

Represent Quality Engineering in all Design Controls and Product Development related aspects Ensure the efficiency of Design Controls (Quality by Design) in projects Promote Advanced Product Quality Planning (APQP) and ensure compliance with relevant standards Actively take part in/facilitate Product Development and Quality Planning processes improvement efforts Apply Quality Engineering principles in a dynamic way to development and production projects Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes Team member in digitalization programs related to QMS and product lifecycle management (PLM Introduction program) Support Risk Management activities Support SMEs in the identification and traceability of critical to quality attributes (CTQs) across all product development phases Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction. Ensure all functions adhere to SHL procedure’s requirements and standards during all development and manufacturing stages. Support cross-site product development, design transfer and continuous improvement projects. Travel internationally up to 10%.

Minimum Requirements

5 years hands-on experience in product development from ideation to launch in the Medical Device industry Expert in Design Controls, Product Development process Knowledge of ISO 13485 and QSR 820.30, ISO 14971, IEC62366, IEC62304 and regulatory oriented Knowledge and proven application of Quality and Lean Methodologies i.e., DFSS, DMAIC, Lean, APQP Experience in establishing processes, procedure writing A solution-oriented growth mindset coupled with decision-making skills Team player and self-starter Able to travel internationally (up to 10%)

Preferred Requirements

Experience in combination products Ability to cooperate in a cross-functional, inter-company and international environment Customer orientation and the ability to identify and effectively manage stakeholder expectations Consensus-building skills to negotiate project deliverables, project risks and priorities

We Offer

A company culture with Focus on Customer, Operate with Ethics and Integrity, Drive Simplicity, Learn and Improve, & Deliver Together. Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast-growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization Flexible hours and hybrid working policy.

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