Description: Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well-being of people around the globe with well-known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, women’s health, and virology. The Senior Quality Systems and Compliance Specialist is responsible for materially participating in maintaining a Quality Management System that meets the needs of the business, policies, and standards. This role also communicates information on the latest QMS standards and regulations, procedures and requirements related to the company’s products and/or services. This role works with others in the organization to ensure Quality Management System processes are compliant to internal and external requirements. ESSENTIAL FUNCTIONS:
- Materially participates in the Corrective and Preventive Action process and the Nonconforming Report system as applicable.
- Conducts internal audits and documents audit findings. Engages with others to assist in performing audits and works with the business process owners to ensure that corrective actions for audit findings are implemented in accordance with company processes.
- Leads and/or supports Quality Management System projects. This includes working with cross functional departments and SMEs to generate project: requirements, schedules, status reports, objective evidence, etc.
- Manages Quality Plans, which includes but not limited to number issuance, uploads plans into Master Control, tracks deliverables, collects objective evidence and associated records
- Carries out duties in compliance with established business policies
- Perform other duties & projects as assigned
Requirements: Education and Experience
- Requires a Bachelor’s Degree (BS/BA) in Engineering/Chemistry/Biology/Technical discipline or equivalent combination education and/or work experience.
- 5 - 8 years of experience in compliance/quality systems. Direct experience in Quality Management System compliance related functional maintenance preferred
- ASQ Certified Quality Auditor or comparable certification and auditing experience are preferred
Skills and Knowledge
- Excellent written and verbal communication skills and must be detail oriented
- Ability to manage multiple projects/audits
- Able to work collaboratively with various departments to identify and implement solutions to address quality/compliance issues
- Ability to make independent Quality System decisions within Internal Audits, CAPA and/or Nonconformance Report systems
- Excellent analytical / critical thinking skills
- Experience with document and summarize complex issues in a clear, succinct, and accurate manner
- Knowledge of the FDA 21 CFR 820 (QSRs) or ISO 13485:2016 is required
- Knowledge of other regulations/guidance (i.e. - IVDD, IVDR, MDSAP, etc.) is preferred
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job
- Precision work; especially as it relates to understanding and documenting complex quality issues.
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies
- 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 Before you apply, please make sure you share Quidel’s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players. Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.