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.
Quality Systems Engineer Huntsville, Alabama Systems Engineering 21692 Astrion is searching for candidates for a full-time Quality Engineer in the Huntsville, AL area....
Position: Software Quality Engineer, Sonova United States Corporate Services, LLC, Aurora, IL. Duties: Ensure and increase software development quality and compliance. Prioritize Release and...
including Corrective Action Preventive Action (CAPA), training, management of change (MOC), and general quality systems support Leading on-going maintenance of global quality management system policies...
Position: Software Quality Engineer, Sonova United States Corporate Services, LLC, Aurora, IL. Duties: Ensure and increase software development quality and compliance. Prioritize Release and...
Report on the performance of the quality system to Company management, as directed, for review and as a basis for improvement of the quality systems....
Senior Quality Systems Engineer- Medical Electrical Equipment
- Arden Hills, MN
- 1 day ago
- Arden Hills, MN
- 1 day ago
Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls....
ISO, Nadcap), customers and Howmet peer groups. * Support supplier quality requirements including SNCRs, SDARs and purchase order review....
[][]This is a job description for a Quality Systems Engineer in Pascagoula, MS.Summary: Bollinger is seeking a Quality Systems Engineer to support the quality management systems, by monitoring welding...
management systems Auditing experience in quality management systems in shipyard, manufacturing or similar setting preferred Certified Welding Inspector (CWI) certification is preferred SKILLS Strong...
. + Adhere to and ensure compliance with Quality System Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), GDP, and FDA requirements Requirements: + Working knowledge of regulated...
Description Description The Health group is seeking a meticulous and experienced Quality Systems Engineer to join our team....
DFMEA, PFMEA) Knowledge and working application of quality management system requirements, in particular ISO 9001 and ISO 13485; familiarity with FDA QSR preferred Solid technical understanding of manufacturing...
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...
Principal Quality Systems Engineer - Supplier Controls SFMD
- Marlborough, MA
- 6 days ago
- Marlborough, MA
- 6 days ago
Recruiter: Spencer Gregory Hale Principal Quality Systems Engineer Location: Marlborough, MA, Arden Hills, MN, or Maple Grove, MN About the Role: As the Principal Quality Systems Engineer for material...
This will include reviewing, interpreting, and applying data and quality system specifications to ensure company processes meet industry standards....
Quality 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
- Process Development
- American Society of Mechanical Engineers
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- IATF 16949
- AS9100
- Production Part Approval Process
- Root Cause Corrective Action
- Quality Engineering
- Advanced Product Quality Planning
- Process Failure Mode and Effects Analysis
- ISO 9001
- Process Validation
- Nondestructive Testing
- Corrective Actions & Preventive Actions
- GxP
- Failure Mode Effects Analysis
- ISO 13485
- Failure Analysis
- Quality Management
- Statistical Process Control
- Minitab
- Validation
- Medical Device Sales
- Document Control
- FDA Regulations
- Root Cause Analysis
- Lean Six Sigma
- Technical Writing
- Continuous Improvement
- Six Sigma
- Engineering
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Investigation
- Mentoring
- Collaboration
- Documentation
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Quality Systems Engineer Related Career Advice Articles

5 Quality Control Career Possibilities
As a specialty that spans numerous industries, QC offers many career paths. Which option is right for you? Read on to learn about the many possibilities available to QC professionals and find the opportunity that fits you best.
Read article »
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »