Director, Quality

About Cala Health

Cala Health Inc., an award-winning bioelectronic medicine company headquartered in the San Francisco Bay area, is transforming the standard of care for chronic disease. The company's wearable neuromodulation therapies utilize electricity as medicine, merging innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, while its vertically integrated commercial model is transforming the delivery of prescription therapies. Cala Health's lead product, Cala Trio™, is the only non-invasive, wrist-worn prescription therapy currently available for essential tremor. Cala Health has new therapies under development in neurology, cardiology, and mental health, and is backed by leading investors in both healthcare and technology. For more information, visit CalaHealth.com.

Our DNA

We're here to empower people to experience greater control over their chronic conditions and more freedom in their daily lives. Our science-first approach and rapid yet rigorous clinical development means we seek excellence in everything we do for customers and our teammates. Inspired by our work, and the talented team members who work with us, we're united in our collective goal to bring about improved, lasting patient outcomes. Join us in building a better future.

The overall compensation range for this role is market driven, with a salary range of $170,000 - $210,000. This market range is based on our base compensation. Additionally, we offer Cala Health company stock options and a robust benefits package. This offering is aligned with our overall compensation philosophy.

Summary

Overall responsibility and accountability for strategy and tactics related to conformance of processes and products to applicable quality standards and regulations to provide the highest quality products to our customers. This position includes people and budgetary management responsibility for quality systems infrastructure and quality engineering resources.

The person in this role serves as the Management Representative for the Cala Quality Management System per ISO 13485:2016 §5.5.2.

Functional Responsibilities:

• Assuring that Cala establishes, maintains, and conforms to a Quality Management System that meets the requirements of all standards and regulations that apply based on the scope of Cala Health designs, devices, and commercial distribution, including but not limited to:
  • Change Control
  • Document Management
  • Quality System Training & Training Management
  • Quality Records Management
  • Complaints Process Management
  • CAPA Process Management
  • Collecting, evaluating, and periodic reporting of Quality Metrics
  • Preparing and Facilitating Management Reviews of the Cala Quality Management System
  • Internal and External Audits
• Establishing and managing Quality Engineering processes and resources to fulfill Cala's Operations needs for:
  • Supplier Quality Engineering
  • Internal Mfg Quality Engineering
  • Receiving, In-Process, and Final Inspection
  • Non-conforming Material Process Management

People and Relationships Responsibilities:

• Providing leadership to teams reporting to this position and coaching, mentoring and developing direct reports to meet or exceed performance expectations
• Aligning department and individual objectives with top level Cala goals, monitoring ongoing progress and performance, and providing timely feedback to the team
• Establishing and maintaining the appropriate organizational structure, resource plans and tactical management to achieve assigned objectives
• Establishing goals and expectations for direct reports and complete regular performance reviews
• Coordinate with regulatory to ensure that processes are designed and operated in conformance with regulations and that process outputs provide the necessary records to support planned regulatory submissions.
• Develop and maintain strong relationships with internal and external stakeholders to ensure the quality system is designed for maximum usability within the constraints of compliance and available resources.
• Contribute to Cala business plans and strategies as the primary interpreter of applicable quality system standards and regulations.

Financial & Budget Responsibilities:

• Prepare annual Quality budgets and forecasts including personnel, operating expenses, and capital expense proposals for Cala Operating Plans
• Provide longer term financial projections for multi-year Cala Strategic Plans
• Monitor actual expenses to plan and take actions required to keep overall spending within budget

Skills and Attributes:

• Exhibits and encourages Cala values of Trust, Bold Innovation and One Team, with a focus on Customers in all dealings
• Consistently manages performance firmly and fairly and in a supportive manner
• Proven leadership and management skills with the ability to optimize team performance
• Strong and confident negotiator with the ability to negotiate at all levels
• Excellent communication, interpersonal and influencing skills
• Excellent analytical and problem-solving abilities
• Results oriented with ability to plan and deliver against project deadlines
• Technical mindset – comfortable with evaluating information of a technical nature related to products and processes

Qualifications and Experience Levels:

• Bachelor of Science Degree required, Master of Science Degree preferred
• Professional training in ISO:13485
• Professional training in Quality System Audit (Internal Audit or Lead Auditor)
• Experience with ISO 14971 Risk Management for Medical Devices
• Demonstrated experience leading a quality function with a proven track record in strategic quality leadership delivering effective quality strategies, policies, processes and systems
• Ability to add value, reduce costs and make business improvements
• Proven project management experience, with the ability to prioritize tasks effectively
• Experience of operating and influencing at a strategic level
• Experience working with Contract Manufacturers preferred
• Experience with NetSuite and Arena, or similar ERP/PLM systems preferred
• Practical experience applying Lean or Six-Sigma methodologies preferred