Quality Engineer II

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:
Key Responsibilities:
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports. This position will be supporting the electrical or implantable subcomponents of the system.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Provide input to the development, update, and maintenance of the technical content of risk management files
• Support training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Ensure design controls are followed through the total product lifecycle. Work with suppliers to address quality issues and supplier change assessments.
• Other incidental duties assigned by Leadership

What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field, 2 years related work experience Required or
Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education Required
 

What else we look for (Preferred):

Additional Skills:
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with FDA regulated industry (medical device experience highly preferred) Working knowledge of ISO 13485, 21 CFR 820, EU MDR highly preferred. Previous experience with electrical devices and their components (e.g. batteries, firmware, PCBs, IEC 60601) and/or implantable devices (e.g. sterilization, biocompatibility, cleanroom environment, sensors, MEMS) strongly desired.
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems. Experience supporting FDA and notified body inspections and audits highly preferred.
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage suppliers and project stakeholders
• Ability to build productive internal/external working relationships

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Illinois (IL), the base pay range for this position is $85,000 to $120,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.