Quality Systems Engineer Jobs in New Hope, MN
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.
Senior Quality Systems Engineer
- Arden Hills, MN (10 miles from New Hope, MN)
- 9 days ago
- Arden Hills, MN (10 miles from New Hope, MN)
- 9 days ago
Responsible for maintaining legacy products, supporting post-market reporting (PMVP, PMVR, PMSR), and managing Quality System deviations....
Senior Quality Systems Engineer
- Maplewood, MN (17 miles from New Hope, MN)
- 45+ days ago
- Maplewood, MN (17 miles from New Hope, MN)
- 45+ days ago
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 (10 miles from New Hope, MN)
- 45+ days ago
- Arden Hills, MN (10 miles from New Hope, MN)
- 45+ 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 New Hope, MN
Moving to New Hope, MN? Find some basic demographic data about New Hope, MN below.
Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in New Hope, MN
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in New Hope, MN 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
- AS9100
- Production Part Approval Process
- CMM Programming
- Advanced Product Quality Planning
- Quality Engineering
- Control Plans
- Capability Maturity Model
- ISO 9001
- Nondestructive Testing
- Failure Mode Effects Analysis
- ISO 13485
- Corrective Actions & Preventive Actions
- Quality Management
- ISO 14001
- Statistical Process Control
- Process Controls
- Aerospace
- Document Control
- Medical Device Sales
- 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
- Reporting
- Collaboration
- Bachelor's Degree
- Policy Development
- Regulations
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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