Our growing company is expanding and we need a reliable and talented engineer to assist in ensuring all processes and end products meet or exceed the quality standards set forth by company, regulatory and customer requirements. We design, manufacture and sell orthopedic implants for the foot and ankle. We have onsite manufacturing and use the latest software for 3D modeling and programming.
This includes but is not limited to managing the investigation and root cause analysis related to customer complaints, audit observations and CAPA items; reviewing, revising and conducting training on SOPs; creating, monitoring and reporting on quality system and business metrics; ensuring the promotion and maintenance of a quality driven culture.
The successful candidate will be responsible for:
• Assist in the development and maintenance of the Quality System to ensure compliance with regulations and requirements including US FDA (21CFR820), ISO 13485
• Participate in and collaborate on global and local regulatory strategy within existing and new product development.
• Ensure internal processes and metrics are aligned to create highest product quality, efficiency and competitive advantage.
• Maintaining the records and investigations related to the non-conformance, corrective action, and customer complaint systems.
• Assist in product development including concept generation, decision matrices, prototyping, manufacturing, verification, validation, and associated metrics
• Assisting Engineering in investigations, qualification, verification and validation protocol development, execution and report generation.
• Assisting Manufacturing by developing process descriptions, maintenance procedures, and training applicable manufacturing staff as needed
• Participate in performance improvement activities, utilize resources efficiently, and effectively take responsibility for own learning needs
• Bachelors of Science
• Degree in Biomedical Engineering preferred
• 3+ years experience in the medical device industry
• Must be proficient in general computer programs such as Microsoft Office and CAD software
• High energy, flexible, self-starter
• Attention to detail and precision in work
• Ability to prioritize and multi-task with little supervision
• Experience demonstrating “out of the box” thinking, strong conceptual, design, and analysis skills, self-motivation, flexibility, detail-oriented work style, professional appearance and attitude, and ability to effectively communicate with customers/clients at all levels
About Trilliant Surgical
Trilliant Surgical creates and manufactures innovative, reliable podiatric products that deliver better patient outcomes while fostering meaningful relationships for the advancement of podiatry. By providing brilliant, high-quality medical devices for small bone orthopedic correction and building strong relationships with surgeons who want to improve patient results and practice economics, we are Champions for Podiatry.