Manager, Quality Engineering
Location
Austin, TX
Level
Manager / Director
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-09-03
Responsibilities
- Lead and mentor a team of quality engineers, providing technical guidance and performance management.
- Develop and implement quality strategies that align with business objectives and regulatory requirements.
- Lead quality engineering support for manufacturing operations, ensuring robust process controls and effective risk management.
- Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
- Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.
- Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges.
- Support internal and external audits, acting as a subject matter expert for quality engineering practices.
Job Requirements
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field); Master’s degree preferred.
- 8+ years of experience in quality engineering within medical devices or other regulated industries, including 3+ years in a leadership role.
- Strong knowledge of ISO 13485, FDA QSR, ISO 14971.
- Proven ability to lead cross-functional teams and manage complex projects.
- Excellent communication, analytical, and problem-solving skills.
- ASQ Certified Quality Engineer (CQE) or similar certifications preferred.
- Experience with orthopedic implants or surgical instruments is a plus.
