Quality Systems Engineer Jobs in Arden Hills, 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.
- Brooklyn Park, MN (9 miles from Arden Hills, MN)
- 2 days ago
- Brooklyn Park, MN (9 miles from Arden Hills, MN)
- 2 days ago
Position Summary: The Quality Systems Engineer position will be responsible for ensuring operational adherence and compliance to Cirtec Medicals Quality Management System (QMS) requirements....
- Plymouth, MN (12 miles from Arden Hills, MN)
- 45+ days ago
- Plymouth, MN (12 miles from Arden Hills, MN)
- 45+ days ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Principal Quality Systems Engineer - Configuration Management
- Arden Hills, MN
- 60+ days ago
- Arden Hills, MN
- 60+ days ago
Familiarity with regulatory standards (e.g., ISO, FDA) and quality management systems (e.g., QMS, CAPA)....
Demographic Data for Arden Hills, MN
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Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in Arden Hills, MN
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in Arden Hills, 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
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- Production Part Approval Process
- IATF 16949
- Root Cause Corrective Action
- AS9100
- Control Plans
- Quality Engineering
- Advanced Product Quality Planning
- ISO 9001
- Corrective Actions & Preventive Actions
- ISO 13485
- Failure Mode Effects Analysis
- Change Control
- Quality Management
- Statistical Process Control
- Workplace Safety
- Manufacturing Engineering
- Process Controls
- Document Control
- Medical Device Sales
- FDA Regulations
- Lean Manufacturing
- Root Cause Analysis
- Lean Six Sigma
- Technical Writing
- Continuous Improvement
- Six Sigma
- Engineering
- Quality Control
- Quality Assurance
- Analytical Skills
- Process Improvement
- Implementation
- Auditing
- Investigation
- Writing Skills
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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