Primary Function of Position: The Senior Quality Systems and Compliance Staff will provide leadership for ISI's quality systems function to ensure the overall quality management system (QMS) align with domestic and global regulatory requirements. Collaboration with business partners and management will be key to create and sustain a QMS infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. The Senior Quality Systems and Compliance Staff will have strong leadership skills to support established customer-focused quality initiatives plus maintain and improve the health of QMS. The leadership skills will serve to manage projects that identify and drive continuous improvements for a robust and agile QMS. Roles & Responsibilities: Provides leadership for Quality Systems and Compliance projects and personnel to ensure the fulfillment of company quality goals and objectives Mentors others for the development and maintenance of a robust quality systems and compliance team Leads and facilitates projects for the development, maintenance and improvement of the company's quality management system with a focus on maintaining robust processes and optimization where feasible Support facility inspections and audits required by government and regulatory agencies on a global basis. Shares responsibility with Regulatory Compliance on maintaining audit readiness for internal and external audits; provides backroom leadership during external audits Provides guidance to business partners and the QSC group in the interpretation of FDA regulations and external regulations/standards pertaining to processes within the quality management system Performs assessments, develops action plans, and drives/facilitates implementation activities to address new requirements from global standards or regulations Supports business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed Develops, maintains and improves processes and procedures for various processes within the quality management system and where necessary, provides training Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate, leads primary quality initiatives within the quality systems Qualification Minimum Bachelor Degree - BS degree in Engineering, Physical or Biological Science, or other technical field Ten plus (10+) years' experience in quality systems, quality engineering, or compliance (or combined experience) in the medical device or other regulated industry Five plus (5+) years' experience in a leadership role with direct management experience strongly preferred Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects Applied understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), India regulations Experience with computer software validation (CSV) regulations/standards and methodologies Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization; and providing training Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficient in constructive dialogue Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness Good understanding of product development lifecycles; design control through post-market surveillance Applied knowledge of risk management, CAPA, and internal/external audit methodologies Practiced in presenting to various levels of management Experience working directly with regulators such as CDSCO, FDA, Notified Body, or other governmental agencies (preferred) Applied knowledge of validation methodologies pertaining to computer system, process and equipment (preferred) Six Sigma Greenbelt certification or other professional certification (e.g., ASQ certification) (preferred) Additional Information Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
