Grifols Shared Services North America, Inc Quality Specialist 3 in San Diego, California
Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensures that deadlines are met on time and within budget. Quality interface with other departments and business or marketing partners. Work independently and exercise judgment within the defined procedures and practices to determine appropriate actions.
Primary responsibilities for role:
Investigates customer complaints and determines root cause
Conducts compliance audits of difficult & complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls.
Serves as QA interface with limited responsibilities to other departments.
Reviews Customer Notifications and prepare, approve & submit data packages for external customers.
Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.
Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.
Chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and other meetings.
Prepares appropriate Agendas and meeting minutes.
Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
Chairs meetings & represents QA as an extended core team member on Core team and crossfunctional special project teams.
May conduct new employee quality system or procedural training and develop department training programs.
Conducts complex technical troubleshooting activities & investigation analysis.
Develops, analyze, trend, maintains & reports department metrics, as needed.
Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
Assists in developing quality systems & make recommendations to existing Quality systems.
Administers QA Programs such as Audit, ECO/DCR CAPA & QSR.
Develops & maintains department training programs.
Review and assess the appropriateness of document changes in accordance with internal procedures of a difficult and complex nature.
Assists in decision making at meetings for recalls, MDRs, field corrections &/or market recalls.
Acts as a mentor to QA personnel.
Knowledge, Skills, and Abilities:
Working understanding of QSR & ISO requirements
Advanced knowlege of QC, Manufacturing & Inventory processes
Working knowledge of Microsoft Word, Excel, 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.
Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.
Requires BA or BS in a biological or chemical science.
Quality certification (from American Society for Quality or equivalent), is a plus.
5-8 years related quality experience.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking and standing are required only occasionally.
Req ID: 218568