Quality Engineer

About the Role

As a Quality Engineer, you will design, implement, and maintain quality assurance protocols and methods for processing materials into finished products. Guide the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspect, test, and evaluate the precision and accuracy of production processes and equipment. Support the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Uphold the company's quality standards and testing systems to reflect efficiency, reliability, and performance. Assist in the creation of documentation to report issues and errors relating to the production process.

Responsibilities

• Review product and process changes for qualification and validation requirements, and assist in change implementations
• Implement systems to ensure timely quality inspections for incoming materials, components, or finished goods products, and perform inspections as needed
• Conduct investigations on complaints or audit issues as quality system feedback is provided
• Support the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging validation
• Assist with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
• Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
• Perform other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Requirements

• Proficient in computer technology including MS Office applications, with good analytical and problem-solving skills
• Able to work efficiently in a team environment
• Strong attention to detail and good organizational skills
• Perform duties in compliance with applicable FDA and State regulations as well as standards including, but not limited to, ISO 13485
• Typically requires a bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience

Physical Demands

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch, or crawl
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Required to possess specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and capacity to adjust focus

Our Values

Our Life Moves Us philosophy is built on four values:

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.