Quality Engineer Device Development

SHL Medical; Deerfield Beach (FL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Modern working environment

Challenging assignments

Opportunities for development

Job summary

SHL Medical is seeking a Quality Engineer to ensure product design effectiveness and compliance with applicable regulations. The role involves representing Global Quality Engineering and supporting various product development and quality planning processes. Candidates should hold a Bachelor's degree in a relevant field and possess 2+ years of quality engineering experience.

We offer a competitive compensation package, modern work environment, and opportunities for personal and professional growth within a dynamic international team.

Qualifications

• 2+ years of experience in Quality Engineering or relevant field.
• Ability to cooperate in cross-functional and international environments.
• A solution-oriented growth mindset.

Responsibilities

• Represent Global Quality Engineering in Design Controls.
• Promote Advanced Product Quality Planning compliance.
• Utilize Quality Engineering best practices.
• Support Risk Management activities for medical devices.

Skills

Knowledge of ISO 13485 and QSR

Quality Engineering

Cross-functional cooperation

Decision-making skills

Team player

Self-starter

Education

Bachelor's degree in relevant field

Job description

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 position of the Quality Engineer 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.
• Performs other related duties as assigned.

Skills And Qualifications

• 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
• Various 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