Quality Engineer

Our client, a leading innovator in the medical device industry, is seeking a Quality Engineer I to join their high-performing team. This is an exciting opportunity for a motivated quality professional with strong technical aptitude, excellent communication skills, and a passion for driving continuous improvement in a regulated manufacturing environment.

As the selected candidate, you will play a key role in supporting manufacturing quality activities, ensuring compliance with global regulatory requirements, and collaborating cross-functionally to resolve issues and enhance processes.

Key Responsibilities

1. Manufacturing Quality & Compliance Leadership

• Serve as a primary QA resource supporting manufacturing operations in alignment with FDA 21 CFR 820, ISO 13485, and MHLW Ordinance 169 requirements.
• Oversee and execute validation activities for processes, equipment, and systems to maintain compliance and ensure state-of-control.

2. Defect Reduction, Nonconformance, and CAPA

• Lead and support initiatives to reduce and control process defects, including scrap, nonconforming material, and customer complaints.
• Drive systematic root cause investigations and implement effective Corrective and Preventive Actions (CAPA) to prevent recurrence.

3. Engineering & Design Transfer Support

• Partner with engineering teams to define and apply quality requirements through design transfer and into manufacturing.
• Facilitate and/or lead cross-functional continuous improvement teams to address systemic issues and strengthen operational processes.

Qualifications

Required

• Bachelor’s degree in a STEM field (Engineering, Science, or related discipline).

• Minimum 3 years of Quality Engineering experience in medical device manufacturing.

• Working knowledge and practical application of:- FDA QSR (21 CFR Part 820)

  • ISO 13485
  • MDD/AIMDD, CMDR, JPAL or other international regulations

• Hands-on experience with nonconforming material systems, CAPA programs, and cross-functional team participation.

• Demonstrated ability in project execution and driving tasks to completion.

Preferred

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Six Sigma Green Belt or Black Belt certification.

Soft Skills & Competencies

• High sense of urgency and strong ownership mentality.
• Excellent verbal, written, and visual communication skills, including presentation and facilitation.
• Ability to build productive interpersonal relationships across functions.
• Skilled in structured, analytical problem-solving.
• Team-driven, collaborative approach with a continuous improvement mindset.
• Strong commitment to execution and follow-through.