Senior Manager - QA / QMS

Qualifications :

Demonstrated compliance knowledge in the areas of medical device and drug product development, change control, CAPA, and risk management.

Strong verbal and written communication skills

Strong interpersonal/communication/influencing/negotiation skills required

Demonstrated leadership, teaming, and communication skills accomplishing success with large teams

Demonstrated business acumen : international experience.

Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, ICH, EMEA, and CFDA regulations and standards for medical devices and therapeutics.

Strong analytical and problems solving skills utilizing DMAIC tools, Six Sigma Engineering, ASQ or other certifications desirable.

Education and Experience

BS Degree (engineering, science, or pharmaceutical related discipline) with 15 + years of experience in medical device industry or MSDegree with 5 years of experience in medical device industry.

5-7 years of leadership experience.

Prior engineering/quality engineering or project management experience with a pharmaceutical product and medical device product.

Demonstrated skill of managing larger team supporting new product initiative and sustanance project with good understating of medical device lab environment.

Essential Duties

Overall responsibility for maintaining site compliance with the requirements of the Vantive Quality Management System (QMS).

Assure excellence in site implementation of the product development process.

Responsible for on-site training on product development, change control, nonconformance / CAPA processes and design best practices.

Establishing and maintaining site QMS certifications, as applicable.

Responsible for building and developing a quality team that are experts in design assurance practices and actively partner with R&D teams to assure a high-quality product.

Collaborate with teams to provide strategy and guidance for meeting Vantive requirements and External Quality Standards as appropriate.

Organize and implement site support of corporate audits and Notified Body regulatory inspections.

Participate in scheduled MRs, Approve, and distribute (or assign a designee to distribute) Management Review minutes

Ensure the Operational Structure's quality system requirements and GxP compliance status are established and effectively maintained per the applicable regulations

Report on the performance of the Operational Structure's quality system to QMR for review and escalates as needed.