Quality Systems Engineer Jobs in Yorba Linda, CA
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.
- Newport Beach, CA (20 miles from Yorba Linda, CA)
- 17 hours ago
- Newport Beach, CA (20 miles from Yorba Linda, CA)
- 17 hours ago
Quality System Engineer is responsible for every phase of the development process to ensure that the design and software adhere to company standards....
Staff Quality Systems Engineer
- Irvine, CA (10 miles from Yorba Linda, CA)
- 10 days ago
- Irvine, CA (10 miles from Yorba Linda, CA)
- 10 days ago
Job title Staff Quality Systems Engineer Function Quality Sub function Quality Systems Category Senior Analyst, Quality Systems (P6) Location Irvine / Plymouth / United States of America Date posted...
Demographic Data for Yorba Linda, CA
Moving to Yorba Linda, CA? Find some basic demographic data about Yorba Linda, CA below.
Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in Yorba Linda, CA
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in Yorba Linda, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Systems Engineer position
- Process Development
- 5 Whys
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- CMM Programming
- IATF 16949
- AS9100
- Production Part Approval Process
- Quality Engineering
- Advanced Product Quality Planning
- Control Plans
- ISO 9001
- Capability Maturity Model
- ISO 13485
- Corrective Actions & Preventive Actions
- Failure Mode Effects Analysis
- Change Control
- Failure Analysis
- Quality Management
- Statistical Process Control
- Workplace Safety
- Minitab
- Process Controls
- Validation
- Medical Device Sales
- Document Control
- FDA Regulations
- Root Cause Analysis
- Specifications
- Lean Six Sigma
- Six Sigma
- Continuous Improvement
- Engineering
- Quality Control
- Quality Assurance
- Auditing
- Implementation
- Investigation
- Documentation
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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