Quality Engineer

Quality Engineer – Medical Device Manufacturing

Location: Olive Branch, MS
Job Type: Full-Time

Join Our Team!

We are seeking a detail-oriented Quality Engineer to join our growing medical device manufacturing team. This position plays a critical role in ensuring products meet the highest quality and regulatory standards while driving continuous improvement throughout the organization.

The ideal candidate will have experience in medical device manufacturing, quality systems, CAPA investigations, validation, and regulatory compliance. If you enjoy solving problems, improving processes, and working in a collaborative environment, we'd like to hear from you.

Responsibilities

• Perform dimensional inspections using a variety of metrology equipment.
• Interpret engineering drawings and apply Geometric Dimensioning & Tolerancing (GD&T) principles.
• Lead investigations involving Corrective and Preventive Actions (CAPA), root cause analysis, and implementation of corrective actions.
• Support equipment, process, and software validations (IQ, OQ, PQ).
• Develop validation protocols, reports, quality procedures, work instructions, and inspection criteria.
• Investigate customer complaints and implement effective corrective actions.
• Serve as the primary quality liaison for customers, addressing quality concerns and supporting customer audits.
• Participate in internal audits and ensure compliance with Quality Management System (QMS) requirements.
• Lead and support Lean Manufacturing and Six Sigma continuous improvement initiatives.
• Train employees on quality procedures, regulatory requirements, and best practices.
• Maintain documentation in compliance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 1271, and applicable regulatory requirements.

Qualifications

• Bachelor's degree in Engineering required.
• 3–5 years of Quality Engineering experience within the medical device industry.
• Strong knowledge of:
• • Metrology
  • GD&T (Geometric Dimensioning & Tolerancing)
  • CAPA investigations
  • Root Cause Analysis
  • IQ/OQ/PQ Validation
  • Quality Management Systems (QMS)
• Experience interpreting engineering drawings.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 1271, and medical device quality standards.
• Strong technical writing and documentation skills.
• Excellent communication, analytical, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Six Sigma Green Belt, Black Belt, or ASQ Certified Quality Engineer (CQE) certification is preferred but not required.

Why Join Our Team?

• Competitive salary based on experience.
• Comprehensive benefits package.
• Opportunity to work with an innovative medical device manufacturer.
• Collaborative and supportive team environment.
• Career advancement and professional development opportunities.
• Make a meaningful impact by helping manufacture products that improve lives.

If you're passionate about quality, regulatory compliance, and continuous improvement, we'd love to hear from you. Apply today and become part of a team committed to excellence in medical device manufacturing.