Quality Systems Engineer Jobs in Santa Cruz, 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.
Senior Quality Systems Engineer
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 7 days ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 7 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Medical Devices Quality Systems Engineer, SaMD
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 18 days ago
- Sunnyvale, CA (23 miles from Santa Cruz, CA)
- 18 days ago
Reality Labs is seeking experienced medical devices quality management professionals to drive the establishment and ongoing operations of a quality management system (QMS) compliant with 21 CFR, EU...
- San Jose, CA (24 miles from Santa Cruz, CA)
- 30+ days ago
- San Jose, CA (24 miles from Santa Cruz, CA)
- 30+ days ago
To ensure its compliance against ISO 9001:2015 Standards and any other relevant standards....
Demographic Data for Santa Cruz, CA
Moving to Santa Cruz, CA? Find some basic demographic data about Santa Cruz, CA below.
Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in Santa Cruz, CA
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in Santa Cruz, CA 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
- Design Control
- Internal Audits
- Supplier Quality
- Quality Systems
- Quality Management Systems
- Production Part Approval Process
- IATF 16949
- AS9100
- Control Plans
- Quality Engineering
- Advanced Product Quality Planning
- ISO 9001
- Corrective Actions & Preventive Actions
- ISO 13485
- Workplace Safety
- Change Control
- Failure Mode Effects Analysis
- Quality Management
- Statistical Process Control
- Manufacturing Engineering
- Minitab
- Process Controls
- Validation
- Document Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Root Cause Analysis
- Complaint Resolution
- Supply Chain
- Lean Six Sigma
- Continuous Improvement
- Engineering
- Product Development
- Six Sigma
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
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