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Manager of Quality Assurance Engineering
2 months ago
As a pivotal member of our team, the Quality Engineering Manager plays a crucial role in ensuring that our products meet the highest standards of quality and compliance. This position is essential in maintaining our commitment to excellence in the healthcare sector.
Key Responsibilities:
1. **Leadership in Quality Engineering:** Provide expert guidance and leadership in Quality Engineering to support the manufacturing of medical devices.
2. **Team Management:** Oversee the development and management of Quality Engineers and Technicians, fostering a culture of continuous improvement.
3. **Post-Production Oversight:** Direct the activities of the Post-Production Quality Engineering team to ensure ongoing compliance and quality assurance.
4. **Regulatory Compliance:** Identify and address opportunities to ensure adherence to internal and external quality regulations, including US 21 CFR 820 and ISO 13485.
5. **Process Control Implementation:** Define and implement effective Process Control and Monitoring systems to manage critical parameters throughout product lines.
6. **Cross-Functional Collaboration:** Lead cross-functional teams to identify and implement Quality Initiatives that enhance product quality and operational efficiency.
7. **Communication and Reporting:** Maintain proactive communication with senior management and peers, providing updates on quality metrics and initiatives.
Qualifications:
- Bachelor's degree in a related field or equivalent experience.
- A minimum of 8 years of experience in the medical device industry, with increasing responsibilities.
- At least 3 years in a supervisory or leadership role.
- Preferred certifications include Six Sigma Black Belt and ASQ Certified Quality Engineer.
- Strong project management skills and the ability to work in a dynamic, matrixed environment.
Why Join Us:
At Abbott, we are dedicated to fostering a diverse and inclusive workplace where you can thrive. We offer comprehensive benefits, including career development opportunities, health coverage, and a supportive work environment. Join us in our mission to improve health outcomes and enhance the quality of life for people around the world.
