We are searching for a passionate and experienced
Quality Engineering Manager fora growing Medical Device company. This person will play a pivotal role in ensuring the highest quality standards for our innovative medical devices, while fostering a culture of quality excellence within our team. You will leverage your deep understanding of medical device regulations and quality management systems to lead and empower a talented team of QA Engineers.
Details: - Hybrid in Carlsbad, CA Tuesday-Thursday
- Competitive salary and benefits package, including health insurance, dental insurance, vision insurance, paid time off, and a 401(k) retirement plan.
- Salary starting at $120,000 + Bonus and Equity
Who You Are:
- A seasoned professional with a minimum of 8years of experience in Quality Engineering for Medical Devices.
- Proven track record of leading and motivating high-performing QA teams in a fast-paced environment.
- Deep understanding of Quality Management Systems (QMS) like ISO 13485:2016 and relevant regulatory requirements (e.g., 21 CFR 820).
- Extensive experience with risk management (ISO 14971) and the ability to translate risk assessments into effective quality control strategies.
- A champion of continuous improvement, with a data-driven approach to problem solving and process optimization.
- Excellent communication, collaboration, and interpersonal skills to effectively partner with cross-functional teams (R&D, Manufacturing, Regulatory).
- Experience with CAPA (Corrective and Preventive Action) processes and complaint investigations.
- Proficiency in quality engineering tools and methodologies (e.g., FMEA, SPC, Gage R&R).
- Strong leadership presence with the ability to mentor and develop team members.
- Bachelor's degree in Engineering, Science, or a related field (Masters preferred).
- Certified Quality Engineer (CQE) a plus.
What You Will Do:
- Lead and manage a team of Quality Engineers, providing guidance, training, and support for their professional development.
- Develop and implement a comprehensive quality strategy that aligns with the company's overall objectives.
- Oversee all aspects of the quality engineering process, including design controls, risk management, verification & validation, and production & process controls.
- Manage and analyze quality metrics to identify trends, opportunities for improvement, and ensure compliance with regulatory requirements.
- Partner with cross-functional teams to integrate quality considerations throughout the product lifecycle.
- Conduct and participate in internal and external audits to maintain compliance with QMS and regulatory standards.
- Foster a culture of quality excellence within the team, promoting continuous improvement and employee ownership of quality.
- Stay up-to-date with the latest trends and best practices in medical device quality engineering.
Partner with Sayva Solutions to find an exceptional opportunity that aligns with your professional aspirations. Our team is dedicated to understanding your unique skills, providing personalized insights to bolster your interview performance, and offering ongoing support throughout the hiring process. Sayva Solutions maintains a vast network and strong relationships with a variety of professionals, enabling us to connect you with exciting job opportunities.
Manager of Quality Engineering