Quality Assurance Manager

POSITION SUMMARY

The Quality Assurance Manager will be accountable for ensuring the company’s smart Total Knee Arthroplasty (TKA) product and future products are designed to meet all regulatory compliance requirements. This leader will report to the Director of Quality Assurance, and will be responsible for the implementation, oversight and maintenance of the Design Controls and Product Risk Management processes, including all Sustaining and Quality Engineering activities.

• Oversee that the Design History Files in accordance with FDA regulations and standards.
• Ensure the Device Master Records are developed and maintain in accordance with FDA regulations including all product process specifications and software specifications, quality assurance procedures, packaging and labeling specifications and installation, maintenance and servicing procedures and methods.
• Develop and maintain validation and verification processes and procedures.
• Interface with research and development, manufacturing, quality, outside consultants and vendors to ensure compliance with internal and external policies and procedures, Quality System regulations and FDA/ISO regulations.
• Maintain supplier qualification, auditing, and surveillance per the QMS.

• Expertise in ISO 14971 application of Risk Management to Medical Devices.
• Understanding of ISO 13485 principles.
• 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.
• Strong influencing and negotiation skills.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.

• Experience with micro-electromechanical systems (MEMS) technologies, and medical devices such as pacemakers, artificial hearts, infusion pumps, diagnostic equipment, or other technologies with design/manufacturing considerations relevant to Canary’s products.
• Advanced education on related areas.
• Certified Lead Auditor.
• Other ASQ or AAMI Certification.

• Bachelor’s degree or more advanced degree in Engineering, or a scientific / technical field is required.
• 10 years of experience in the medical device industry.

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: $110,000 - $165,000. 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:

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 legal requirements.