Manager of Quality Assurance
2 weeks ago
As a pivotal member of our team, the Quality Engineering Manager will oversee the development and implementation of quality assurance strategies within the organization. This role is essential in ensuring that our products meet the highest standards of quality and compliance.
Key Responsibilities:
1. Lead and mentor a team of Quality Engineers and Technicians, fostering a culture of excellence and continuous improvement.
2. Manage the Post-Production Quality Engineering team, ensuring adherence to quality standards and regulatory requirements.
3. Identify and implement proactive measures to enhance compliance with internal and external quality regulations, including US 21 CFR 820 and ISO 13485.
4. Drive initiatives aimed at risk reduction, cost efficiency, and budget management to add value to the organization.
5. Establish and maintain superior Process Control & Monitoring systems for critical parameters across product lines.
6. Collaborate with international partners to promote quality improvements and share best practices.
7. Lead cross-functional teams in executing Quality Initiatives, ensuring effective communication and collaboration.
8. Monitor and report on Quality Metrics, taking action to address any performance declines.
9. Champion the principles of Quality, Six Sigma, and Lean methodologies throughout the organization.
Qualifications:
- Bachelor’s degree in a related field or equivalent experience.
- Minimum of 8 years in the medical device industry, with a focus on quality assurance.
- Proven leadership experience, with at least 3 years in a supervisory role.
- Six Sigma Black Belt and ASQ Certified Quality Engineer certifications are highly preferred.
- Strong project management skills and the ability to work in a dynamic, matrixed environment.
- Excellent communication skills, capable of engaging with various levels within the organization.
Why Join Us:
At Abbott, we are committed to creating a diverse and inclusive workplace where every employee can thrive. Join us in our mission to enhance health and well-being globally.
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