Quality Systems Engineer Jobs in Salem, MA
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
- vascular access inc
- Billerica, MA (17 miles from Salem, MA)
- 6 days ago
- Billerica, MA (17 miles from Salem, 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 Person- Philips
- Bedford, MA (18 miles from Salem, MA)
- 60+ days ago
- Bedford, MA (18 miles from Salem, MA)
- 60+ days ago
Quality Systems Engineer Job Description The Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision...
In PersonDemographic Data for Salem, MA
Moving to Salem, MA? Find some basic demographic data about Salem, MA below.
Quality Systems Engineer Online Courses and Training Opportunities
Salary for Quality Systems Engineer Jobs in Salem, MA
Required or preferred licenses and certifications for Quality Systems Engineer positions.
Highest Education Level
Quality Systems Engineers in Salem, MA 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
- Quality Assurance
- Engineering
- Auditing
- Investigation
- Process Improvement
- Documentation
- Implementation
- Reporting
- 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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