Senior Quality Assurance Manager

POSITION PURPOSE:

The Senior Manager of Quality Assurance is responsible for working with all levels of employees in providing strategies that include the development and implementation of a sustainable and compliant Quality System and supporting MDD/MDR Transition International regulatory product submissions.

ESSENTIAL FUNCTIONS:

• Position will help manage multidisciplinary company functions of the Regulatory and Quality departments and is authorized to sign and approve quality system documents requiring regulatory approval.
• Assist the company through MDD/MDR transition and maintenance of CE Certification.
• Work with the VP of Clinical Affairs in providing strategic direction for clinical studies activities.
• Provide strategic and tactical RA and QA initiatives to support the business objectives and patient quality focus.
• Assists CEO in short/long-term project planning.
• Work with R&D to determine clinical feasibility of new products and all required documentation related to developing and implementing new products.
• Conduct critical assessments via internal audits of ALL processes and equipment to identify areas of improvement
• Conduct Management Reviews as scheduled, be responsible for evaluation and dissemination of company quality standards, initiatives, guidelines.
• Maintain Quality Assurance programs, policies, processes, and procedures to ensure that performance and quality of products conform to established standards
• Establish and maintain International product and manufacturing certifications
• Establish and maintain training curricula required for employees to ensure compliance with regulations, standards, HIPAA and EHS.
• Interact with the FDA and international governmental agencies on a global basis regarding regulatory and compliance issues.
• Review sales and marketing materials for conformance to regulatory requirements.
• Participate in the Company's strategic development & implementation of Quality Systems.
• Help make decisions to release or hold commercially approved products based upon conformance to requirements.
• Assure compliance to worldwide regulatory requirements based upon Quality Program assessments.
• Initiate and ensure quality complaints are fully investigated, documented, and reported in compliance with SOP's
• Establish and manage compliant Validation and SDLC (Software Development Life Cycle) Programs

EDUCATION/EXPERIENCE REQUIREMENTS (including certifications, licenses, etc):

• Minimum of 8 years' experience in management of regulatory and quality for medical devices (Class I/II/III). In depth knowledge of ISO regulations.
• A minimum of a bachelor's degree in science, engineering, biology related field.
• Demonstrated success in development of clinical and regulatory strategies, through all phases of deployment such as protocol development, site selection, and trial execution.
• Successful management of major multi-center, prospective pivotal clinical trials. Proven leadership in compliance with respect to regulations and guidelines related to clinical strategy, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, and medical device reporting.
• Demonstrated success in building and managing RA and QA departments.
• Ability to function in a small company, "hands-on" environment.
• Self-starter. Ability to operate in a small company dynamic environment.
• Ability to drive meetings with various stakeholders:

o NSAI, NMPA, MFDS, FDA

o Expert advisors.

• Excellent attention to detail.
• Passion, energy, personal drive and motivation.

COMMUNICATION SKILL REQUIREMENTS:

• Strong written, verbal and presentation skills, including the ability to present, persuade and convince regulators, investors and key opinions leaders with respect to the company's products and RA and QA strategies.
• Ability to review, understand and explain the appropriate guidance documents (NMPA, MFDA, FDA) to guide the project team is required.