Engineering
Located in:
Athens, TX
Pay: $55,000-$65,000/year
Job Full Description:
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.
Athens, TX
Darby Scheffer
darby.scheffer@expresspros.com
+1 903-592-9999
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