Connect Life Science
Director of Quality
Connect Life Science, Santa Clara, California, us, 95053
Director of Quality / Snr / VP
Bay Area, CA | Full-Time Position | On Site Role
Medical Devices
Competitive Salary, Benefits & Stock
The Company
Join a cutting-edge medical device organization dedicated to transforming patient care. With a focus on innovation and life-saving solutions this company operates in a fast-paced startup environment, the team embraces challenges with enthusiasm and a commitment to delivering top-quality medical devices that make a real difference in patient outcomes.
The Opportunity
We are searching for a
Director of Quality
to lead and shape the quality functions. This high-impact role is ideal for a skilled professional who excels in problem-solving, navigating complex challenges, and driving operational excellence. This is a senior leadership position whilst being very much a hands-on role. This is your chance to contribute to a growing organization while leading quality initiatives that ensure compliance, improve processes, and foster innovation in a highly regulated industry. An exciting time to join a thriving and growing start-up, with excellent financial backing and runway, heading towards big things in the next 2 years! What You'll Do Lead
strategic quality projects , including implementing electronic quality management systems (eQMS), achieving ISO 13485 certification, and ensuring product compliance with global regulations. Manage all quality functions, including sterilization and biocompatibility testing Act as a key representative during regulatory inspections and audits, ensuring alignment with FDA, EU MDR, and MDSAP standards. Provide mentorship and leadership to quality team (8-10 people), cultivating a culture of compliance and excellence. What You Need to Succeed Education & Experience: Bachelor’s degree in biological sciences, engineering, or a related field and 10+ years of experience in quality / regulatory role within the medical devices. 10+ years of experience managing and mentoring quality teams. Experience in vascular, cardio, neuro or catheter fields in MedTech Key Skills: Deep knowledge of quality system regulations (ISO 13485, EU MDR, MDSAP). Proven experience with CAPA processes, sterilization standards, and statistical analysis tools (e.g., Six Sigma), Complaint Handling, Non-conformance, and Management Review. Exceptional leadership, communication, and problem-solving abilities. Strong project management skills with a track record of implementing scalable quality system improvements. Why Join? This is an opportunity to work at the forefront of medical innovation, leading impactful projects and being a key player in a product-focussed and high-growth environment Apply now for a call back week commencing 9th December!
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Director of Quality
to lead and shape the quality functions. This high-impact role is ideal for a skilled professional who excels in problem-solving, navigating complex challenges, and driving operational excellence. This is a senior leadership position whilst being very much a hands-on role. This is your chance to contribute to a growing organization while leading quality initiatives that ensure compliance, improve processes, and foster innovation in a highly regulated industry. An exciting time to join a thriving and growing start-up, with excellent financial backing and runway, heading towards big things in the next 2 years! What You'll Do Lead
strategic quality projects , including implementing electronic quality management systems (eQMS), achieving ISO 13485 certification, and ensuring product compliance with global regulations. Manage all quality functions, including sterilization and biocompatibility testing Act as a key representative during regulatory inspections and audits, ensuring alignment with FDA, EU MDR, and MDSAP standards. Provide mentorship and leadership to quality team (8-10 people), cultivating a culture of compliance and excellence. What You Need to Succeed Education & Experience: Bachelor’s degree in biological sciences, engineering, or a related field and 10+ years of experience in quality / regulatory role within the medical devices. 10+ years of experience managing and mentoring quality teams. Experience in vascular, cardio, neuro or catheter fields in MedTech Key Skills: Deep knowledge of quality system regulations (ISO 13485, EU MDR, MDSAP). Proven experience with CAPA processes, sterilization standards, and statistical analysis tools (e.g., Six Sigma), Complaint Handling, Non-conformance, and Management Review. Exceptional leadership, communication, and problem-solving abilities. Strong project management skills with a track record of implementing scalable quality system improvements. Why Join? This is an opportunity to work at the forefront of medical innovation, leading impactful projects and being a key player in a product-focussed and high-growth environment Apply now for a call back week commencing 9th December!
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