Quality Engineer

Position Summary

Designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. Guides the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Supports the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Upholds 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.

Essential Functions

• Reviews product and process changes for qualification and validation requirements and assists 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 into complaints or audit issues as quality system feedback is provided.
• Supports 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.
• Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products.
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures 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.
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Qualifications

• 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.
• Bachelor's degree in engineering discipline

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 visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and capacity to adjust focus.