Quality Systems Engineer Jobs
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.
- Great Lakes Dredge & Dock Company, LLC
- Oakbrook Terrace, IL
- 16 hours ago
- Oakbrook Terrace, IL
- 16 hours ago
The opportunity: Quality Systems Engineers are exposed to multiple facets of our dredging projects with responsibilities for safety, quality control, quality assurance, documentation, and supporting...
In PersonJOB SUMMARY: Works with all levels of leadership and front-line staff to facilitate and support the development and integration of evidence-based best practices at the department/program level...
In PersonThe Quality Systems Engineer will act as a guardian of Quality, shaping a Quality Management System that thrives on speed, security, and scalability....
In PersonThe Quality Systems Engineer is responsible for supporting and leading Quality System activities for new product development and commercial finished goods, including validations, resolution of non-conformances...
In PersonSystems Engineer Quality Systems Engineer Electrify America is committed to revolutionizing the way people charge....
RemoteSenior Quality Systems Engineer
- vascular access inc
- Billerica, MA
- 6 days ago
- Billerica, MA
- 6 days ago
Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus Lead auditor certification (ISO 13485 or equivalent) is a plus Experience with implementing and validating...
In PersonUnited States Steel Corporation has an immediate opening for a Quality Systems Engineer in our Quality Management System/Corporate Quality Assurance organization....
In PersonJOB PURPOSE AND REPORTING STRUCTURE:Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system...
In PersonThe SGL site in St. Marys, Pennsylvania, is our largest graphite component processing site worldwide. It is characterized by its broad product portfolio and expertise in machined, purified and CVD...
In PersonSenior Quality Systems Engineer
- ANDURIL INDUSTRIES
- Ashville, OH
- 12 days ago
- Ashville, OH
- 12 days ago
ABOUT THE TEAM Anduril's Quality organization is seeking a Senior Quality System Engineer to join our team and help develop future opportunities for our internal quality management system and digitization...
In Personsystem projects....
HybridQuality Systems Engineer Tucson, AZ (Onsite) | Aerospace & Avionics 9/80 Schedule Available – Every Other Friday Off Quality Systems Engineer – Be the Backbone of Aerospace Excellence At Universal Avionics...
In Person- Spectrum Plastics Group
- Pleasant Prairie, WI
- 14 days ago
- Pleasant Prairie, WI
- 14 days ago
of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820....
In Personstandards for products and processes through effective implementation of the Quality Management System (QMS)....
HybridA global consumer products company is building out a newly formed Global Quality Systems team as part of a large-scale digital transformation initiative supporting Quality, Safety, Regulatory, and Compliance...
In PersonQuality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs Nationwide
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Systems Engineer position
- Windchill
- 5 Whys
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- Production Part Approval Process
- AS9102
- Root Cause Corrective Action
- Internal Audits
- AS9100
- IATF 16949
- Control Plans
- Failure Mode Effects Analysis
- Advanced Product Quality Planning
- Quality Management
- Quality Engineering
- Statistical Process Control
- ISO 9001
- Corrective Actions & Preventive Actions
- ISO 13485
- Process Controls
- Change Control
- Document Control
- Aerospace
- Medical Device Sales
- FDA Regulations
- Root Cause Analysis
- Lean Six Sigma
- Continuous Improvement
- Six Sigma
- Technical Writing
- Change Management
- Engineering
- Auditing
- Investigation
- Process Improvement
- Documentation
- Implementation
- Reporting
- Data Analysis
- Collaboration
- Bachelor's Degree
- Regulations
- Microsoft Office
- Project Management
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
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