Senior Quality Systems Engineer

Biomerics • Brooklyn Park, MN

72d

About The Position

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

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.

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 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

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees