Design Assurance Quality Engineer

Description

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here  improve and advance the lives of our employees and the patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

The Design Assurance Quality Engineer provides Quality Engineering support for new product development (NPD) projects from concept through design transfer and commercialization, while also supporting sustaining engineering activities for existing products throughout their lifecycle. This position partners with Design Engineering, Manufacturing Engineering, Operations, Supplier Quality, Business Development, and Quality to ensure customer, quality, and regulatory requirements are appropriately incorporated throughout product development and ongoing product support.

The Design Assurance Quality Engineer supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product/process change activities in accordance with the Quality Management System (QMS) and applicable regulatory requirements. This position reports to the Site Quality Manager.

• Provide Quality Engineering and Design Assurance support throughout the new product development lifecycle, from concept and prototyping through design transfer and production for BBPK and BSLC sites.
• Manage and support quality deliverables associated with the design process, including Design History File (DHF) and Engineering Project File documentation.
• Participate as the Quality representative on cross-functional design and development teams to ensure customer requirements, product specifications, quality requirements, and applicable regulatory requirements are appropriately documented and addressed.
• Collaborate with Design Engineers and Technicians in the development, review, execution, and documentation of verification and validation protocols and reports.
• Support design control activities, including review of design inputs, design outputs, design reviews, verification, validation, and design transfer documentation.
• Participate in the development and maintenance of DFMEAs, PFMEAs, and product Risk Management documentation, ensuring risks are appropriately identified, evaluated, mitigated, and documented.
• Collaborate with Supplier Quality to ensure new suppliers are appropriately qualified and new components, raw materials, and purchased products meet applicable specifications and quality requirements.
• Support the qualification and validation of new materials, components, manufacturing processes, equipment, and test methods as required.
• Author, assist, and approve where applicable the development and validation of inspection methods, acceptance…