Quality Engineer Device Development

Job Overview

The position of the Quality Engineer at SHL Medical holds responsibility for the effectiveness and quality of product design and process developments ensuring its compliance with applicable regulations. The job holder is directly involved in the establishment and application of efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.

Main Responsibilities

• Represent Global Quality Engineering in all Design Controls and Product Development related aspects
• Support the application of Design Controls (Quality by Design) in projects
• Promote Advanced Product Quality Planning and ensure compliance with relevant standards
• Actively take part in/facilitate Product Development and Quality Planning processes improvement efforts
• Support the application of 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
• Applies Quality Engineering tools, techniques and methodologies to product development according to the company’s needs and applicable regulations.
• Support Risk Management activities for medical devices and the device part of drug/device combination products for SHL Medical products are of high quality and directs product development decisions by promoting a Risk-Based approach.
• Support SMEs in the identification and traceability of CTQs
• 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.
• Perform other related duties as assigned.

Skills and Qualification

• Bachelor's degree (or equivalent) in a relevant field, preferably in science or engineering.
• 2+ years Quality Engineering or other relevant experience
• Knowledge of ISO 13485 and QSR, ISO 14971, IEC62366, IEC62304.
• Ability to cooperate in a cross-functional, inter-company and international environment.
• A solution-oriented growth mindset coupled with decision-making skills.
• Team player and self-starter.

We Offer

• Competitive compensation package
• 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
• Variety of opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer.

This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

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

How we hire

We like to keep things simple and efficient. Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter. Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are. Grounded in belonging, we strive for excellence.