Sr. Manager, Quality Systems

Quality          ·        San Mateo, CA (Hybrid)         ·       Full time

About the job

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

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 Opportunity

Cala Health is seeking a Sr. Quality Systems Manager to join our growing team. The role will report to our Sr Director, Regulatory & Quality.

Specific Responsibilities also include

• Maintain Cala Quality System adherence to 21 CFR 820 and ISO 13485 (EU MDR)
• Coordinate and support Management Review and be responsible for execution of the quality system across functions
• Support Management Representative, act as Management Representative Designee
• Lead internal audits, support external audits
• Directly manage and coach performance of members of the quality team
• Nurture and provide development opportunities to direct reports
• Communicate objectives and priorities to direct reports
• Work across functions with peers to ensure collaboration for shared goals
• Cultivate an environment of integrity and adherence to ethical standards
• Manage and provide input into budget process
• Apply proactive, systematic problem-solving methods in identifying, prioritizing, communicating and implementing Quality objectives
• Manage Quality System tools and processes
  • Document Control
  • Metrics
  • Incoming Inspections and NCMR
  • Deviations
  • Complaints and Post-Market Surveillance
  • External Standards
  • QMS Training
  • Production and Process control
  • Risk Management
  • Supplier Quality
  • Manufacturing Process and System Support
• Direct data collection and analysis to monitor test result trends
• Other Key Roles:
  • Management Representative Designee

Desired Skills and Experience

We are looking for a Sr. Quality Systems Manager to support Cala Health in a dynamic, fast-paced startup environment, exemplified by:

• 7-10+ years of Quality experience and Regulatory knowledge in the medical device industry
• Bachelor’s degree in a technical or science major
• Demonstrated knowledge of relevant US and international requirements, including US QSR (21 CFR 820), US IDE (21 CFR 812), ISO Quality System (ISO 13485), FDA guidance documents pertinent to design control and software, and similar
• Auditing experience relative to 21 CFR 820 and ISO 13485 quality systems
• Practical application of conventional engineering and statistical methods
• Ability to hire, train and retain key personnel
• Proven track record of effectively and constructively managing direct reports, as well as leading work efforts of team members beyond the direct reporting structure
• Highly effective written and oral communication skills, including skill at drafting, reviewing, and editing documentation for internal Quality System and also for review by third-party regulatory agencies
• Organized, detail-oriented, and adaptable according to evolving situations at hand

Cala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status,
sexual orientation, religion, color, ethnicity, race or any other legally protected classification. If you or someone you know might be interested in this position, please submit a resume & an introductory email to careers@CalaHealth.com.

Cala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-jobrelated disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Please click here to apply.