Company: Intuity Medical, Inc.
Location: Sunnyvale, CA
Website: www.intuitymedical.com
Intuity Medical is a medical device company developing a greatly simplified glucose monitoring system for people with diabetes. The Company's proprietary technology re-invents the glucose testing procedure making it easier and more convenient to use.
This novel technology profoundly changes the competitive landscape of the $6 billion + glucose testing industry. Testing convenience is cited as one of the biggest barriers to frequent glucose testing and Intuity’s new approach will revolutionize the way people test.
Intuity is a well funded private company backed by top-tier venture capital firms known for their successes in the medical device industry. This individual will have an opportunity to launch a unique product with breakthrough potential in one of the largest clinical diagnostic markets.
Position summary:
The Director of Quality Assurance & Regulatory Affairs is responsible for the implementation and maintenance of Intuity’s Quality System including reporting on the performance of the Quality System. The Director of QA/RA is a member of the Senior Management Team and is the Management Representative for the company. The Director will represent the facility to all external Quality System Assessment agencies, such as Notified Body Representatives, FDA and State Inspectors. The individual will have the unique opportunity to lead the quality and regulatory efforts needed to develop and launch the first product for Intuity Medical. The Director is also responsible for developing and managing Intuity’s internal audit program and supplier audit program. The Director is also responsible for managing the development of Quality System training programs.
Highlights:
• Successful track record of establishing quality systems from ground up
• Experienced in domestic and international regulations (FDA, ISO, etc.)
• Experienced in supplier quality set-up and management
• Experienced in defining, managing, and obtaining regulatory certification
• Experienced with successful submission and attainment of 510(k) clearance
• Experience in successful completion of FDA and ISO 13485:2003 audits
• Glucose monitoring category experience desired
Duties and Responsibilities:
• Provide the vision, leadership and teamwork environment necessary to build an organization capable of achieving department and company goals
• Provide leadership and management to QA/RA department staff
• Able to interact with HR in regards to personnel conflict/resolution
• Develop effective Quality Systems to assist with timely development and launch of successful products
• Establish and manage systems and processes to ensure compliance with all regulations including design control
• Develop and implement methods and systems to assure that development as well as production teams receive support in the following areas:
a) Quality planning, including inspection techniques and sampling methods
b) Statistical analysis
c) Provide guidance and interpretation of regulatory requirements for functional areas
• Prepare, review, approve, issue, and/or maintain Quality System documentation and procedures in accordance with relevant regulations
• Manage internal and external resources to ensure timely launch of new products using processes consistent with the Company quality systems
• Manage quality and regulatory activities in line with the Company’s expectations and policies, working within a defined budget
• Represent the Company’s quality and regulatory activities to the Board of Directors, investors, medical community, potential collaborators and the public at large
Required Skills:
• 10-15 years of successful experience in establishing quality systems for product development, with demonstrated leadership and increasing responsibilities progressing to Director level, preferably in the glucose monitoring industry
• Successful track record in defining and launching innovative products, demonstrated by successful product launches, ideally for glucose monitoring, point-of-care, or diagnostic related product groups
• Experience in working with technical groups and able to translate regulations to technical requirements
• Ability to lead a diverse team of professionals, gain their respect and be able to coach and direct the team with a “hands-on” approach
• Strong collaboration, team building and development skills
• Ensure organizational readiness for audits by regulatory bodies
• Extensive knowledge in domestic and international regulations and guidelines
• Highly intelligent, self confident, and possess effective analytical and problem solving skills
• Have a personality that is adaptable and a good fit with an emerging, start-up company
• Be a high energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people
Desirable Skills:
• Drive and coordinate the regulatory efforts around submission and attainment of 510(k) clearance for Intuity products
Education/Training:
• The preferred candidate will have at least a Bachelor’s in Sciences, Engineering or related field with a minimum of 10 years of experience in Medical Device Industry.
Mailing address:
Intuity Medical, Inc
Attn: Staffing
350 Potrero Avenue
Sunnyvale, CA 94085
Qualified candidates please submit a confidential resume in MS Word format with salary requirements to: careers@intuitymedical.com or fax 408-530.1711.
For more information about Intuity Medical please go to our website at www.intuitymedical.com.
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