Vice President, Global Quality will provide leadership and overall strategic direction to Quality Department that support organization within a Class II-III, medical device development environment to ensure compliance with regulatory requirements as well as alignment with company objectives and Quality standards. As dynamic, resourceful and strategic thinker he/she will provide results-oriented leadership to sustain and improve a world class robust and efficient Quality organization.
VP Global Quality will be a member of executive management team reporting to Senior Vice President, Regulatory Affairs, Clinical Research and Quality and will supervise a global organization encompassing product development and multiple manufacturing sites worldwide. Typical duties:
- Provide strategic leadership and direction to global Quality organization to ensure efficiency and compliance of company products and processes to corporate and regulatory requirements
- Participate in development and lead the execution of Quality strategies and goals commensurate with the Company objectives
- Lead the implementation of strategies to sustain and improve a global Quality organization to support the product lifecycle management from concept to product realization followed by post market surveillance to ensure business compliance, growth and sustainability.
- Lead continuous improvement processes to enhance operational efficiency and efficiency of global Quality systems aligned with FDA and global regulatory requirements.
- Provide strategic oversight of all segments of Corporate QMS
- Lead the continuous evaluation of all Quality systems and processes and recommend and direct implementation of appropriate enhancements to ensure the achievement of the Company’s near-term and long-term objectives.
- Provide guidance and direction in regulatory inspections and audits
- Interface directly with FDA, Notified Bodies, and other regulatory agencies on matters pertaining to processes, products or Quality systems compliance.
- Lead the development and tracking of company quality indicators utilizing contemporary statistical tools and methodologies.
- Provide expertise and guidance in interpreting government regulations and guidelines related to QMS and regulatory compliance as they apply to products and practices.
- Ensure that the organization is trained to the highest standards of Quality excellence and technical competency utilizing best in class processes and practices.
- Oversee the development of a risk assessment strategy reflective of the Company’s philosophy and approach to assessing and managing risk.
- Lead recruitment and efforts to retain and develop first class talent responsible for providing Quality support to all company operations.
- Establish the culture to build and sustain employee engagement by fostering efficient execution of strategies and a coaching environment in which individuals and teams can excel and continuously grow.
- Job ID 5765BR
- Aliso Viejo, California, USA
Apply for this job
- Bachelor’s Degree in Engineering, Quality Management or related science discipline.
- Twenty (20+) years of experience in medical device quality operations, quality assurance, quality systems, and/or compliance role.
- A minimum of eight (8) years in a senior Quality leadership role with increasing responsibility.
- Strong knowledge of Statistical Process Control.
- Ability to develop strong collaborative relationships with all functional departments of the organization.
- Possess a flexible, pro-active approach to problem solving, be an adept negotiator and applyrisk-based decisions.
- Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards.
- Ability to effectively and efficiently manage consultants, vendors and budgets.
- Advanced degree (MS, PhD, MBA).
- Experience with implantable medical devices.
- Comfortable in a results-driven, highly accountable environment where you can make an impact
- Self-motivated, able to work independently and be reliable and responsive
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Strong professionalism and interpersonal skills
- Demonstrated practice of constructive engagement and possession of the confidence to challenge and be challenged to get the best strategies and solutions
- Experience in leading change throughout an organization to enhance and sustain a world-class quality culture
- Demonstrated ability to work as a senior leader and to engage the cross functional senior leadership team as needed.
- Demonstrated ability to lead, develop and sustain Quality team
- Some experience in operations, manufacturing, and/or R&D.