Senior Vice President of Quality Assurance
2 weeks ago
Position Overview:
Connect Life Science, a pioneering entity in the medical device sector, is on the lookout for a seasoned Vice President of Quality to spearhead their quality management initiatives as they transition innovative products into the market. This pivotal leadership position entails comprehensive oversight of quality assurance and regulatory adherence, ensuring excellence throughout the stages of product development, manufacturing, and market introduction.
Ideal Candidate Profile:
The successful candidate will possess a robust background in the medical device arena, showcasing a deep understanding of quality frameworks, regulatory mandates, and the intricacies of product commercialization. Exceptional leadership qualities, strategic foresight, and the ability to thrive in a dynamic, highly regulated landscape are critical.
Core Responsibilities:
- Direct quality systems and guarantee adherence to FDA, ISO, and other regulatory requirements.
- Champion quality initiatives from the inception of product development to successful market entry.
- Oversee internal and external audits, implement corrective measures, and drive continuous enhancement efforts.
- Engage collaboratively with Research & Development, Manufacturing, and Regulatory Affairs teams.
- Provide strategic guidance to facilitate effective product launches and ongoing market support.
Required Qualifications:
- Significant experience in quality leadership roles within the medical device industry.
- In-depth knowledge of regulatory compliance, risk assessment, and quality management systems (ISO 13485, FDA 21 CFR Part 820).
- Demonstrated success in guiding products from the development phase to market readiness.
- Strong capabilities in leadership, communication, and problem-solving.
This role presents a distinctive opportunity to contribute to a forward-thinking organization at a crucial juncture in its evolution.
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