Quality Engineer

About the Role:

Quality Engineer

We are seeking a detail-oriented Quality Engineer to oversee and improve the quality standards of products and processes within highly regulated environments. In this role, you will ensure that manufacturing and software processes meet rigorous internal standards and external global regulations. You will be instrumental in identifying risks, validating systems, and maintaining the integrity of life-critical technologies.

• Quality Management Systems (QMS): Maintain and improve QMS frameworks in accordance with ISO 13485 and ISO 9001 standards.
• Validation & Verification: Author and execute IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for equipment and software systems.
• Risk Management: Lead Risk Management activities, including FMEA (Failure Mode and Effects Analysis), to identify and mitigate potential points of failure in the production lifecycle.
• Compliance & Auditing: Conduct internal audits and support external regulatory inspections to ensure strict adherence to 21 CFR Part 820
  , HIPAA
  , and GDPR
  .
• Root Cause Analysis: Investigate non-conformances (NCs) and implement Corrective and Preventive Actions (CAPA) to resolve systemic quality issues.
• Data-Driven Improvement: Utilize statistical process control (SPC) and data analytics to monitor manufacturing performance and drive continuous improvement.

• Education: Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Quality Management, or a related technical field (Required).
• Experience: 0–5 years of experience in quality assurance, manufacturing engineering, or academic projects involving technical documentation and process analysis.
• Technical Skills (Required):
• Proficiency in Statistical Analysis (Minitab, Excel, or JMP).
• Strong understanding of SDLC (Software Development Life Cycle) and GAMP 5 principles.
• Knowledge of 21 CFR Part 11 regarding electronic records and signatures.
• Familiarity with Six Sigma or Lean Manufacturing methodologies.
• Preferred
  
  Skills:
  
  
• Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green/Black Belt
  .
• Familiarity with CAD software (Solid Works/AutoCAD) for reviewing technical specifications.
• Understanding of medical device regulations (MDR) and clinical safety standards.

• Targeted Placement: Direct marketing to our network of hiring managers in the Medical Device and Med Tech industries.
• Resume Rebuild: Optimization of your profile to highlight Quality Engineering competencies and regulatory expertise.
• Interview
  
  Coaching:
  
  Guidance on CAPA case studies, validation logic, and quality-centric behavioral interviews.

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