Primary purpose and function of this position:
The primary responsibility of the QA Device Director is to lead the company’s Combination Product related activities, from a quality perspective.
Major duties and responsibilities:
· Managing the Combination Product Quality System aspects. Responsibility for all tasks related to quality issues.
Note: Neuroderm is ISO 13485:2016 accredited.
· Leading Combination Products related audits and assisting in any other agency audits, including follow up on received observations.
· Writing different types of documents (e.g. procedures, protocols), based on the applicable requirements.
· Reviewing and Approving on behalf of QA Controlled Documents such as:
a. Validation Master Plan and Report
b. V&V protocols and reports
c. Software-related documents
d. Product requirements documents
· Reviewing and Approving on behalf of QA Change Controls/ ECOs, CAPAs, Complaints and Deviations in NeuroDerm Quality System.
· Supporting the device development process. This includes being a part of the design definition, risk management activities, attend process meetings and design reviews.
· Reviewing current compliance practices and suggesting innovative approaches to improve compliance and processes.
· Ensuring the company’s Medical Device products release process from a quality perspective.
· Any other task assigned by the direct manager.
Reports To: VP Quality
Competencies:
· Self-starter with a willingness and desire to succeed
· Excellent technical understanding
· Flexible and able to work with deadlines
· Good organizational and planning skills
· Ability to multi task and on a variety of projects
· Exellent attention to detail skils
· Good interpersonal, written, oral and presentation skills
· Teamplayer who can also operate alone
Education and Knowledge Requirements:
· Bachelor’s degree in Engineering or a relevant degree plan is required.
· An American Society for (ASQ) Certified Quality Engineers or Certified Quality Manager (CQM) certification is recommended.
· Familiar with relevant regulatory requirements. At a minimum- FDA 21 CFR 820 regulations, ISO 13485 and ISO 14971. Familiarity with IEC 62304 and IEC 60601 is recommended.
· At least 5 years experience in establishing and maintaining Combination Product or Medical Device Quality Management. Including, but not limited to Medical Device Design and Development process (including software), Supplier Qualification, CAPA, Non-conformance and Change Controls.
· Good computer skills including full control of Microsoft Office applications.
· Fluent in Hebrew and English (writing and speaking)
