Director, Quality Assurance

Posted 16 July 2024
Salary 190,000-230,000
LocationSan Diego
Job type Permanent
Discipline Quality
Reference200794
Contact NameJeremy Burling

Job description

Responsibilities:
  • Ensure compliant conduct per QSR, ISO, and corporate requirements as the designated management representative for the site
  • Support the realization of new products through new product development, third party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls
  • Develop, communicate and build consensus for quality goals, objectives and programs that support business unit and company goals; identify and make recommendations for strategic direction within the site and/or business unit
  • Prepare and maintain the departmental budget; effectively make decisions to utilize resources maintaining department budget while meeting department and business unit goals
  • Develop site and/or organizational policies and authorizes their implementation
  • Oversee the development, maintenance, and improvement of the Quality Management System, including promoting QMS harmonization across sites and identifying opportunities for improvement within the QMS and related systems
  • Liaise with manufacturing as it relates to Quality, including internal audits, incoming materials and product distribution
  • Partner with IT and QARA leadership to maintain and enhance the learning management system and other QMS systems as the administrator for the site
  • Ensure appropriate QSR and ISO audits are performed for critical suppliers and service organizations; ensure proper quality agreements are maintained per Company procedures
  • Attend QA Global One meetings to discuss global initiatives, challenges, etc.
  • Support cross-company projects and/or new product development as the site Quality contact between SMD (or other Subsidiary Companies)
  • Provide QA support and direction for contract manufactured products
  • May lead Corrective and Preventative Action (CAPA) investigations and resolve potential product quality issues as they relate to compliance or continuous improvement
  • Demonstrate commitment to the development, implementation and effectiveness of Company’s Quality Management System per ISO, FDA, and other regulatory agencies
  • Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
  • Carry out duties in compliance with established business policies

Background Requirements:
  • Bachelor's degree in a scientific field; Advanced degree preferred
  • 10+ years relevant work experience in IVD (reagent and/or instrumentation) industry or related experience preferred
  • Managerial and lead auditor experience preferred
  • Thorough knowledge of FDA QSR, ISO 13485, MDSAP, and Japanese requirements (Specific requirements, regulations, and directives are identified in Site Quality Manual and/or SOP’s and/or Policies)
  • Ability to create and maintain budgets
  • Proficient with ERP and electronic QM systems
  • Comfortable in a leadership role, including providing direction to directors and senior managers in various areas and/or groups
  • Ability to consistently work with abstract ideas or situations across functional areas of the business; through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and direction for resolution of issues
  • Exhibits professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices