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 at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.

JOB DESCRIPTION

We are seeking a Sr. Quality Systems Engineer to oversee key quality functions including CAPA, Nonconforming Material, Document Control, and Training programs. This role will serve as a Subject Matter Expert, drive system improvements, and support internal audits. The specialist will collaborate with cross-functional teams to ensure compliance with product and quality requirements, support new product introduction, and assist in process and inspection development.

Requirements:

• Bachelor’s Degree/Technical Degree in applicable field or equivalent industry experience
• Minimum 5 years’ experience in a Medical Device manufacturing/product development environment
• Working knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements
• Experience with Nonconforming Material, Corrective and Preventive Actions, Training for both Direct and Indirect Labor, and working knowledge of Quality Management System software.
• Experience/knowledge with product/process verifications/validations
• Experience with development and support of Quality Systems as they relate to standards
• Must possess good project management skills and initiative in taking on and completing projects
• Must possess advanced verbal and written communication skills
• Must be able to manage and prioritize multiple projects/objective

RESPONSIBILITIES

• Direct oversight of the Nonconforming Material and Corrective and Preventive Action system.
• Direct oversight of the Direct and Indirect Labor Training program.
• Ownership of the document control quality management system.
• Initiate and drive improvements to systems supported by this role.
• Act as primary Subject Matter Expert on systems supported by this role.
• Participate as backup Internal Auditor as time permits.
• Work with cross functional teams to develop or improve quality systems related to standards and current business needs.
• Participate on Manufacturing Engineering/Operations teams to assure customer product requirements as well as quality requirements are documented and addressed.
• Interface with customer on labeling design, development, and packaging considerations.
• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.
• Work with Manufacturing Engineering, Operations and QC Inspection in the development and qualification of processes.
• Assist with the development of inspection processes and equipment if and when required.
• Work with R&D, Manufacturing Engineering, Operations, and Quality, during concept, prototyping, and transfer of new products into production.
• Other assignments as requested.

Requirements:

• Bachelor’s Degree/Technical Degree in applicable field or equivalent industry experience
• Minimum 5 years’ experience in a Medical Device manufacturing/product development environment
• Working knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements
• Experience with Nonconforming Material, Corrective and Preventive Actions, Training for both Direct and Indirect Labor, and working knowledge of Quality Management System software.
• Experience/knowledge with product/process verifications/validations
• Experience with development and support of Quality Systems as they relate to standards
• Must possess good project management skills and initiative in taking on and completing projects
• Must possess advanced verbal and written communication skills
• Must be able to manage and prioritize multiple projects/objectives