Quality Systems Engineer Jobs in New Jersey
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.
The Quality Systems Engineer II drive TMC's Corporate CAPA Program to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, MDR etc.), effective...
Demographic Data for New Jersey
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Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in New Jersey
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in New Jersey offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Systems Engineer position
- Industrial Engineering
- American Society of Mechanical Engineers
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- AS9100
- Production Part Approval Process
- Root Cause Corrective Action
- Quality Engineering
- Advanced Product Quality Planning
- ISO 9001
- Process Validation
- Nondestructive Testing
- ISO 13485
- Corrective Actions & Preventive Actions
- GxP
- Failure Mode Effects Analysis
- Failure Analysis
- Quality Management
- Statistical Process Control
- Workplace Safety
- Manufacturing Engineering
- Process Controls
- Minitab
- Validation
- Medical Device Sales
- FDA Regulations
- Root Cause Analysis
- Specifications
- Lean Six Sigma
- Technical Writing
- Six Sigma
- Continuous Improvement
- Engineering
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Investigation
- Mentoring
- Collaboration
- Documentation
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Microsoft Excel
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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