Director, Quality Assurance

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

We are seeking an experienced and dynamic Director of Quality Assurance to join our team. As the Director of Quality Assurance, you will play a pivotal role in ensuring the quality, safety, and compliance of our medical devices. You will lead a team of quality professionals and be responsible for implementing and maintaining a robust Quality Management System (QMS) to meet regulatory requirements and industry standards. The role will be managing Quality Control and the Quality Management System teams. Your leadership will drive a culture of continuous improvement and excellence in quality throughout our organization. This position reports to the Head of Quality Assurance.

RESPONSIBILITIES:

Quality Management System (QMS) Leadership:

• Develop, implement, and maintain an effective QMS in compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.

• Oversee the documentation and training programs related to the QMS, ensuring that all employees understand and adhere to quality procedures.

• Streamline Quality Systems and processes to support commercial growth.

• Commercial Complaint Processing with MDR/Vigilance experience is required.

Quality Operations:

• Responsible for the day-to-day management of the Quality Control activities.

• Responsible for assuring MRB control and timeliness.

• Provide support and establish alignment with Manufacturing and Operations.

• Implement metrics to identify commercial key improvements.

Quality Compliance:

• Stay up to date with all relevant FDA and regulatory requirements and ensure that our product and processes remain compliant.

• Organize, review and prepare the Management Reviews. Represent Quality in management review.

Audits, Compliant Handling and CAPA:

• Oversee the complaint handling and corrective and preventive action (CAPA) processes to ensure timely resolution of issues and prevention of recurrence.

• Managing both internal and external audit, interface with regulatory body.

Quality Strategy and Continuous Improvement:

• Develop and execute the quality strategy to drive product quality and process efficiency improvements.

• Establish key performance indicators (KPIs) and quality metrics to monitor and report on the effectiveness of the QMS.

Team Leadership and Development:

• Recruit, train, and manage a high-performing quality assurance team.

• Foster a culture of quality, teamwork, and continuous learning within the department.

Supplier Quality Management:

• Collaborate with suppliers to ensure the quality of raw materials and components used in our products.

• Conduct supplier audits and assessments as needed.

• Management of the Supplier Corrective Action program.

Quality Risk Management:

• Lead risk management activities to identify, assess, and mitigate potential quality risks associated with our products.

• Develop a compliant new product development process with adherence to FDA Design control requirements and Risk Management ISO 14971 standards. Strong understanding and ability to apply risk benefit for commercial situations as needed.

Cross-Functional Collaboration:

• Collaborate closely with R&D, Manufacturing, Regulatory Affairs, Clinical, HR and other departments to integrate quality into all aspects of product development and manufacturing.

QUALIFICATIONS:

• Minimum of 10 years of progressive quality assurance experience in the medical device, electrosurgical industries (Class II, Class III, or PMA).

• Minimum 8+ years' experience as a manager; and 5+ years' experience in a senior managerial role.

• Strong knowledge of FDA regulations, ISO13485, and other relevant quality standards.

• Experience in medical device development, including development, manufacture and launch of Food and Drug Administration (FDA) reviewable medical products.

• Must have hands-on experience with supporting commercial medical device manufacturing and operations.

• Experience with Document Control and electronic QMS.

• Demonstrated management skills, including leadership, talent assessment, recruitment, retention, and development.

• Excellent communication and interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact. Ability to communicate technical information to non-technical audiences.

• Ability to work effectively and independently in a fast-paced, dynamic environment.

• Familiar with quality engineering, design and software verification and validation.

• Experience with identification of relevant compliance standards and associated testing.

• Bachelor's degree in related field; master's degree a plus.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options

• 90% employer-paid medical, dental, and vision insurance

• Company-paid Basic Life Insurance

• 401(k) retirement plan (Traditional and Roth)

• Competitive Paid Time Off

• Paid Holidays

• FSA (Flexible Spending Accounts)

• HSA (Health Savings Account)

• Employee Assistance Program through PEO

• The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $195,000 - $210,000

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.

At this time, we are unable to offer relocation assistance at Element Science.