Sr Quality Assurance Specialist

About the role

Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist.

Responsibilities

• Manages nonconformances, Out-of-Tolerance Reports, and CAPA records, ensuring timely corrective actions and comprehensive documentation.
• Leads quality meetings, represents QA in daily meetings, and drives quality improvements through operational analysis and compliance audits.
• Improves procedures, conducts risk assessments, prepares for audits, manages metrics, mentors junior staff, and develops training programs.
• Reviews and approves manufacturing documents, leads projects, makes data-driven decisions, facilitates training sessions, and acts as a backup to the department Supervisor/Manager.

Requirements

• At least a BA or BS in biology, chemistry, biochemistry or biomedical engineering (Quality certification (from American Society for Quality or equivalent) is a plus).
• 5-8 years related quality experience relatable quality including nonconformances, CAPAs, compliance audits, and OOT reports (with a Bachelors) or a master’s degree with 3-6 years of experience.

Qualifications

• Advanced knowledge of complaint handling, nucleic acid testing instrument (hardware and software), QC, Manufacturing & Inventory processes.
• Working knowledge of SAP/Salesforce, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs.
• Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
• Demonstrated initiative, independence, balanced assertiveness, flexibility and team orientation.
• Ability to train and mentor within and outside the group.

Skills

• Knowledge of medical device regulatory requirements.
• Track and trending for PHSC.
• Leadership in cross-functional teams.
• Coordination of regional meetings with field service engineers and field service representatives.
• Interaction with regulatory and partner auditors/inspectors.

Benefits

• Medical, Dental, Vision, life insurance, PTO, paid holidays.
• Up to 5% 401(K) match and tuition reimbursement.