Quality Management System Developer
Primarily responsible for the strategic development of our quality management system in accordance with relevant regulatory requirements for medical devices. Oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership.
Serves as an active member
of hub and spoke teams (led by GPOs) to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
Key Areas of Responsibility
* Ensure QMS compliance with the appropriate internal and external regulatory requirements.
* Ensure optimum state of QMS for current and future business needs.
* Identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
* Drive development and/or modification of Stryker's QMS.
* Audit and quantify requirements for QMS requirements to optimize structure.
* Ensure GMP and GDP compliance within Quality organization.
* Provide guidance for the development, maintenance, and improvement to policies and procedures to increase the efficiency and effectiveness of the QMS.
* Ensure development and delivery of training for QMS areas of expertise.
* Drive development of best-in-class practices and benchmark against industry leaders and regulatory requirements.
* Liaise with notified bodies to manage certification changes.
Additional Responsibilities
* Coordinates input, feedback, and represents their division's needs.
* Accountable for local process and training implementation.
* Updates the GPO and/or PMO on divisional deliverables and progress.
* Ensures the global initiatives in their area are communicated and understood by divisional stakeholders.
* Serves as the voice for their division in the process area.
* Travels to hub and spoke meetings.
Requirements
* BS in a science, engineering, business or related discipline.
* Minimum of 7 years experience in manufacturing environment or equivalent preferred.
* Experience in regulated environment and interaction with regulatory agencies required.
Knowledge / Competencies
* Thorough knowledge and understanding of US and International Medical Device Regulations.
* Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.).
* Strong communication, project management and influencing skills.
Estimated Salary: $120,000 - $180,000 per year.