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.
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...
Additional information can be found at www.ttm.com Scope: This Quality Systems Engineer is responsible for operating the Quality Management System (QMS), writing procedures and processes to support...
Proficiency in quality management software and tools. ASQ Certified Quality Engineer Certification Preferred or Certified Quality Manager (CQM)-ASQ Certification Preferred....
Position Summary: The Quality Systems Engineer position will be responsible for ensuring operational adherence and compliance to Cirtec Medicals Quality Management System (QMS) requirements....
Description We are actively seeking a seasoned Senior IT Manufacturing Quality Systems Engineer to spearhead the implementation and optimization of electronic Quality Management Systems (eQMS) throughout...
Summary: This position provides high level technical quality engineering support and development of the QMS, Training and other Quality related applications....
Job Description: Senior Quality Systems Engineer POSITION SUMMARY We are seeking a dynamic, analytical thinking individual to join our Quality team, focusing on Quality Systems, CAPA, Internal Audit...
least 3-5 years of experience in quality engineering, quality systems, or a related field, preferably within manufacturing or production environments.Strong knowledge of quality management systems,...
Management (e.g., ASQ Certified Quality Engineer) is a plus...
About the Role: The Senior Quality Systems Engineer will be responsible for the execution of Field Action (FARS) Investigation Reports in the Business Warehouse (BW) application used as an input to...
Senior Quality System Engineer (Hardware & Production) Salt Lake City
- Salt Lake City, UT
- 5 days ago
- Salt Lake City, UT
- 5 days ago
Quality System Engineer (Hardware & Production), you will play a crucial role in ensuring the quality and regulatory compliance of the hardware components of medical devices and in ensuring quality...
-9001), by participating in various forms of Quality Management System (QMS) auditing and responding to assigned findings....
Arwood Machine, A VulcanForms Company seeks a Staff Quality Systems Engineer for our Newburyport, MA Facility Job Purpose As a Staff Quality Systems Engineer, you will be responsible for ensuring the...
As a Quality Systems Engineer, this position is responsible for ensuring that our Field Lines of Business (ISO 9001) and Corporate Functional Teams meet the highest quality systems management standards...
Key Responsibilities: Safety & Compliance: Maintain a safe work environment across all operations and tasks. Drive safety initiatives to achieve Incident and Injury-Free goals, supporting site...
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
- Product Lifecycle Management
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- Production Part Approval Process
- IATF 16949
- Root Cause Corrective Action
- AS9100
- Control Plans
- Quality Engineering
- Advanced Product Quality Planning
- ISO 9001
- Corrective Actions & Preventive Actions
- ISO 13485
- Failure Mode Effects Analysis
- Change Control
- Quality Management
- Statistical Process Control
- Workplace Safety
- Manufacturing Engineering
- Process Controls
- Document Control
- Medical Device Sales
- FDA Regulations
- Lean Manufacturing
- Root Cause Analysis
- Lean Six Sigma
- Technical Writing
- Continuous Improvement
- Six Sigma
- Engineering
- Quality Control
- Quality Assurance
- Analytical Skills
- Process Improvement
- Implementation
- Auditing
- Investigation
- Writing Skills
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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