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.
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
- 2 days ago
- Marlborough, MA
- 2 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....
Job title Senior Quality Systems Engineer Function Quality Sub function Quality Systems Category Senior Analyst, Quality Systems (P6) Location Palm Beach Gardens / United States of America Date posted...
Quality Systems Engineer (Aerospace/Defense AS9100/NADCAP)
- Salt Lake City, UT
- 3 days ago
- Salt Lake City, UT
- 3 days ago
Job Title: Quality Systems Engineer (Aerospace/Defense AS9100/NADCAP) Location: SALT LAKE CITY UT 84104 Schedule: Monday Friday, 8:00 AM 4:30 PM (Overtime as needed) Compensation: Hourly (Approx. $70,000...
Knowledge of basic Quality Systems, FDA, ISO, and good documentation practices Preferred qualifications: Excellent interpersonal and communication skills Experience in Quality System compliance and...
LifeSciences Quality Systems Engineer Location: Virginia Beach Department: LifeSciences Quality Systems Job Type: Full-Time Shift: Monday-Friday, Full Time Clinical Classification: Non-Clinical LifeNet...
Position Summary: The Quality Systems Engineer position will be responsible for ensuring operational adherence and compliance to Cirtec Medicals Quality Management System (QMS) requirements....
Quality Systems Engineer CAPA and Process Improvement
- Manchester, NH
- 7 days ago
- Manchester, NH
- 7 days ago
Key responsibilities as a Quality Systems Engineer: Own and manage the full CAPA processfrom intake and investigation through corrective actions and effectiveness checks....
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings out the...
Management System) and maintain it in real-time + Establish test standards by item, register revised versions, and analyze measurement system (MSA) + Plan, drive, and coordinate certification initiatives...
Remote WorkQuality 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
- Industrial Engineering
- American Society of Mechanical Engineers
- Supplier Quality
- Internal Audits
- Quality Management Systems
- Quality Systems
- AS9100
- Production Part Approval Process
- Root Cause Corrective Action
- Quality Engineering
- Advanced Product Quality Planning
- ISO 9001
- Process Validation
- Nondestructive Testing
- ISO 13485
- Corrective Actions & Preventive Actions
- GxP
- Failure Mode Effects Analysis
- Failure Analysis
- Quality Management
- Statistical Process Control
- Workplace Safety
- Manufacturing Engineering
- Process Controls
- Minitab
- Validation
- Medical Device Sales
- FDA Regulations
- Root Cause Analysis
- Specifications
- Lean Six Sigma
- Technical Writing
- Six Sigma
- Continuous Improvement
- Engineering
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Investigation
- Mentoring
- Collaboration
- Documentation
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Microsoft Excel
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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