JOB DESCRIPTION SUMMARY

The Quality Engineer 3 role is responsible for quality design assurance activities for Instruments and Software on various projects, working within a broader quality engineering team. This role will have the responsibility for the implementation of design control processes and quality assurance processes required for the development of medical devices.
The role will have interaction with global quality teams.
Responsibilities include representing the quality function during new product development and sustaining projects to ensure customer expectations are met, instruments, software and reagents are developed with high quality and reliability, and in adherence to applicable regulations.

ABOUT THE ROLE

• Bachelor’s degree in engineering or equivalent experience
• Minimum of 4 years working in design and/or manufacturing process development, preferably for medical devices
• Demonstrated knowledge of ISO 13485 and FDA QSR regulations
• Experience working with quality systems such as ISO 9001/ AS9100 and ISO 13485
• Ability to read technical drawings and schematics
• Strong problem-solving skills and ability to analyze complex situations
• Excellent verbal and written communication skills
• Knowledge of statistical methods used in data analysis (e.g., Minitab) is preferred
• Understanding of basic mechanical principles and tolerances
• Proven track record of successful project management and team leadership
• Demonstrated ability to work independently as well as part of a team
• Must be able to travel up to 10% of time domestically and internationally

MAIN RESPONSIBILITIES WILL INCLUDE:

• Ensure all aspects of product design meet regulatory requirements and are in compliance with relevant standards.
• Collaborate closely with cross-functional teams including Product Development, Engineering, Manufacturing, Marketing, Sales, and Regulatory Affairs to ensure new products are designed and developed according to specifications.
• Conduct risk assessments and implement mitigation plans where necessary.
• Review product designs for manufacturability, reliability, safety, and compliance with regulatory standards.
• Work closely with manufacturing partners to develop manufacturing processes and procedures.
• Develop and maintain quality control protocols for new products.
• Monitor and evaluate product performance during clinical trials.
• Provide input on product labeling and documentation.
• Support regulatory agency inspections and audits.
• Lead quality assurance activities related to new product launches.
• Assist in developing training programs for employees involved in design, manufacturing and testing processes.
• Keep abreast of industry trends and best practices related to quality assurance.
• Collaborate with other departments to identify potential issues and propose solutions.
• Ensure adherence to quality standards throughout the entire product lifecycle.