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Director Of Quality Assurance, Tioga Cardiovascular

Posted on Nov. 28, 2024 by Shifamed LLC

Los Gatos, United States of America
$180000.0 - $220000.0

Full Time

Director Of Quality Assurance, Tioga Cardiovascular

Tioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

This position is responsible for the development, implementation, and management of quality systems and practices. This position will oversee and ensure that the development, manufacture, testing and release of products are performed according to the applicable federal and state regulations, international standards, and the Company’s Quality Policy. This is a full-time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

Establish, implement, and maintain company quality systems in compliance with FDA, International Standards (ISO), and other regulatory agencies.
Manage communication and act as liaison with regulatory agencies on compliance issues, including registration and licensing of facilities and regulatory agency audits and inspections.
Perform the responsibilities of Management Representative. Establish, promote, communicate, and support the Quality policy and objectives for quality; ensure the Quality Policy is understood, implemented, and maintained at all levels of the organization.
Conduct internal and external (e.g., vendor) compliance audits; report results and recommendations for change as required.
Review and approval all controlled documents (e.g., work instructions, quality specifications, engineering specifications, procedures, and validation protocols).
Coordinate and/or provide training to staff in Quality System Regulations/GMP/ISO/MDD and Quality Systems awareness; assist in the development and maintenance of training materials and records.
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
Proactively recommend policies and maintain a robust quality system to ensure compliance with FDA Quality System Regulations, ISO 13485;2003, and the Medical Device Directive (MDD).
Ensure compliance with company quality assurance policies and practices by participating in product and material reviews, assist in “troubleshooting” problems related to the manufacture, test, validation, and documentation of devices.
Review and approval all lot history records and sterile load records to ensure product compliance with specifications and regulatory requirements.
Act as primary Quality signature authority, and alternate signature authorities as assigned.
Coordinate attention to customer complaints, corrective actions, Medical Device Reports (MDRs), vigilance activities, and product field actions. As required research and investigate product failures and the reasons for such.
Ensure that adequate resources are provided to support Quality System activities and to comply with applicable regulatory requirements.
Assure company objectives are defined, achieved, and maintained supporting company registrations and certifications.
Monitor the activities supporting the goals and initiatives for overall suitability, effectiveness, and profitability of the company.
Execute the company’s executive Management Review process to identify actions to improve the Quality System when appropriate.
Represent the Quality Assurance function in project team meetings.
Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality.
Ensure that all staff are trained in applicable procedures prior to performing Quality-related activities; inform responsible personnel of concerns involving product quality.
Must be willing to work in fast paced challenging environment and set up initial quality system that is pragmatic and practical for a small company.
Must be willing to work deeply in early-stage R&D environment and have experience in bringing first-of-a-kind medical devices to initial human use, including ramp-up of pilot production.
Perform job functions in a safe and effective manner.
Other duties as assigned.

Education & Work Experience

Bachelor’s/Master’s in engineering or scientific discipline, or equivalent relevant work experience.
7+ years Quality or technical Management experience in the medical device or a related field.
Previous direct people management experience.
Previous experience bringing a company into regulatory compliance and approval, both domestically and internationally, preferred.
Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
Solid knowledge of international regulations, standards, and guidelines (current MDR, ISO 13485).
Ability to train others in processes and procedures.
Excellent communications skills (both written and verbal) required.
Ability to work effectively across functional lines to reach effective outcomes for the business.
Ability to travel as required.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $180,000 to $220,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.

Advertised until:
Dec. 28, 2024

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