Quality Systems Engineer Jobs in Minnesota
A Regulatory Affairs Specialist in the quality control industry is responsible for ensuring that an organization's products comply with all applicable domestic and international regulatory standards and guidelines. They play a crucial role in the product development process by providing regulatory guidance and strategies, preparing and submitting documentation for regulatory approvals, liaising with regulatory authorities, and maintaining knowledge of evolving regulatory requirements. They may also be involved in reviewing marketing materials, training materials, and product labels to ensure regulatory compliance.
A Regulatory Affairs Specialist should possess strong analytical, communication, and project management skills. They must be detail-oriented, with a strong understanding of scientific and technical information. Familiarity with regulatory affairs software and databases is also beneficial. Relevant certifications such as the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) are often preferred by employers. Prior roles that can lead to a career as a Regulatory Affairs Specialist include Quality Control Analyst, Product Development Scientist, or Compliance Officer.
Responsible for maintaining legacy products, supporting post-market reporting (PMVP, PMVR, PMSR), and managing Quality System deviations....
including Corrective Action Preventive Action (CAPA), training, management of change (MOC), and general quality systems support Leading on-going maintenance of global quality management system policies...
Senior Quality Systems Engineer- Medical Electrical Equipment
- Arden Hills, MN
- 30+ days ago
- Arden Hills, MN
- 30+ days ago
Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls....
Demographic Data for Minnesota
Moving to Minnesota? Find some basic demographic data about Minnesota below.
Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in Minnesota
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in Minnesota offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Systems Engineer position
- Product Lifecycle Management
- American Society of Mechanical Engineers
- 5 Whys
- Supplier Quality
- Internal Audits
- Quality Systems
- Quality Management Systems
- IATF 16949
- Production Part Approval Process
- AS9100
- Quality Engineering
- Advanced Product Quality Planning
- Control Plans
- ISO 9001
- Nondestructive Testing
- Failure Mode Effects Analysis
- ISO 13485
- Corrective Actions & Preventive Actions
- Quality Management
- Statistical Process Control
- Workplace Safety
- Process Controls
- Aerospace
- Mechanical Engineering
- Medical Device Sales
- Document Control
- Root Cause Analysis
- FDA Regulations
- Specifications
- Lean Six Sigma
- Continuous Improvement
- Technical Writing
- Six Sigma
- Engineering
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Investigation
- Mentoring
- Documentation
- Collaboration
- Bachelor's Degree
- Policy Development
- Regulations
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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Here are some other career titles that require similar skills
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