Senior Quality Systems Engineer at Biomerics

Description

Company Overview: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation 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. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.

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

JOB DESCRIPTION:

Provide Quality Systems, Engineering, and Compliance support for the Biomerics Quality Management System.

JOB 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 QSRs, ISO 13485, and ISO 14971 requirements.
• Experience with Nonconforming Material, Corrective and Preventive Actions, Direct and Indirect Labor Training, and working knowledge of Quality Management System software.
• Experience/knowledge with product/process verifications/validations.
• Experience developing and supporting 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.

Requirements

• 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 in Manufacturing Engineering/Operations teams to ensure customer product and quality requirements are documented and addressed.
• Interface with customers on labeling design, development, and packaging considerations.
• Collaborate with Supplier Quality to ensure 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 developing inspection processes and equipment 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.

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k, On-Site Fitness Facility

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are estimates from this job board and not a guarantee from Biomeric's salary range.

Biomerics only accepts non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.