Principal/Manager of Quality Assurance

POSITION SUMMARY

Canary Medical is currently seeking either a Principal or Manager of Quality Assurance to be responsible for the oversight and maintenance of the Canary Quality Management System documentation and establish the on-market product performance data capture, analysis, and reporting system to support monitoring and measurement activities of the Quality Management System. This role will implement, improve, or further develop existing procedures for systems process development in collecting and analyzing data for development and continuous improvement of the QMS in collaboration with quality engineering functions for process and product improvement activities.

SCOPE AND RESPONSIBILITIES

• Support/Manage the Quality Management System and subsystems including but not limited to Customer Complaints/Feedback, Change Management, Document Control, Non-Conformance, Field Returns, Corrective and Preventive Action and Internal Audit.
• Establish the product experience, returns categories and adverse event reporting (MDR) from existing Risk Management Files ensuring risk assessment is integrated into complaints management process.
• Develop reports and metrics for KPI’s as an input to Management Review.
• Maintain efficient tools and processes for receiving product experience information from customers.
• Develop reports and metrics to monitor the status of product on the field and product reliability (PMS) for periodic quality review reporting as an input to the CAPA system and management review.
• Support the development through manufacture transfer activities in preparation for post-market activities.
• Oversee the implementation of product lifecycle management software tools for electronic tracing of product requirements.
• Support front and back-room audit support for Internal and Notified Body Audits, or FDA inspection activities.
• Manage field action activities as needed.

Required Knowledge, Skills and Abilities:

• Effective cross-functional collaboration and with key stakeholders to swiftly achieve results.
• Working knowledge in post market surveillance (PMS) and adverse event reporting (Medical Device Reporting/MDR).
• Ability to anticipate issues, identify problems and implement proactive solutions.
• Full understanding of ISO 13485, Part 820 Quality System Regulation & MDSAP.
• Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, to perform critical job functions, trending, and reporting.
• Strong communication, facilitation, planning, and problem-solving skills.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.
• Hands-on leader.

Preferred Knowledge, Skills and Abilities:

• Part 806 Correction and Removals.
• Part 803 Medical Device Reporting.
• Certified Lead Auditor.
• Other ASQ or AAMI Certification.
• Working knowledge of ETQ system.

Education and Experience Requirements:

• Bachelor’s degree or more advanced degree in Engineering.
• 6+ years of experience in the medical device industry.
• Experience working in a start-up environment.
• Experience scaling QA processes.

Department: Regulatory Affairs and Quality Assurance

Reports to: Director of Quality Assurance

Travel: Minimal travel may be required

Work Location: Hybrid in Carlsbad, CA

Employment Type: Exempt: accordingly, you are expected to work all hours necessary to complete the job responsibilities set forth above.

Salary: The estimated base salary range for the Quality Manager (HYBRID) role based in the United States of America is: $120,000 - $160,000. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, experience, education, location where the role is to be performed, internal equity, and alignment with market data. The base pay range is subject to change and may be modified in the future. Additionally, employees may be eligible for our variable cash program (bonus) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits including medical/dental/vision, FSA, long-term disability, AD&D, unlimited PTO, a flexible work environment and unparalleled culture.

Benefits:

• Unlimited PTO
• FSA plan
• Paid holidays
• 401k plan
• Medical, dental, and voluntary vision insurance
• Voluntary Life & AD&D
• Voluntary Long-Term Disability

COMPANY BACKGROUND:

Canary Medical

Canary Medical is a medical technology company focused on commercializing smart implants in the orthopedic, cardiovascular, and aesthetics markets. The company has established a considerable intellectual property portfolio surrounding its CHIRP (Canary Health Internal Reporting Processor) technology to facilitate development of active implanted devices capable of monitoring patient function utilizing MEMs sensor technology in concert with sophisticated power management algorithms and wireless data transmission.

The Canary ecosystem is comprised of an implantable smart device, a base station to transmit data from the device to a secure cloud structure, and a HIPAA-compliant cloud software system to store the information, convert the raw data to useful metrics, present said data on Patient and Clinician user interfaces, and mine data for clinical insights. The Summatix platform is adjunctive and seamlessly integrated with the Canary cloud enabling Clinicians to harness CMS RPM CPT codes in the delivery of patient care.

Canary both develops its own FDA approved products and partners with major and minor manufacturers to incorporate its smart CHIRP devices into their partner’s FDA approved devices, allowing transmission of information without clinical interpretation or medical intervention. This minimizes the regulatory burden on the medical device partner, as clinically interpreted data fall under the usual FDA regulatory pathways.

The company has a robust product pipeline in several therapeutic areas and is targeting a smart Total Knee Arthroplasty (TKA) implant as its first commercial US product within the next months, followed in quick succession by other total joint arthroplasty products (hip, shoulder) since approximately 90% of their core technology is shared across these areas. Canary’s cardiovascular efforts are targeting aneurysm, heart valves, and coronary stents monitoring. This aspect of the Canary product pipeline is earlier in development but is likewise expected to leverage core technologies from the orthopedic pipeline to reduce time to market, project costs, and regulatory risk.

Disclaimer:

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.

Canary Medical is proud to be an equal opportunity and affirmative action employer. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state, or local law. We also consider qualified applicants regardless or criminal histories, consistent with lega