Quality Specialist 3

GRIFOLS, S.A.•San Diego, CA

6d•$97,000 - $115,000•Onsite

About The Position

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.

Requirements

Working understanding of QSR & ISO requirements
Advanced knowledge 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.
BA or BS in a biological or chemical science.
5-8 years related quality experience.

Nice To Haves

Quality certification (from American Society for Quality or equivalent), is a plus.

Responsibilities

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.
Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes.
Leads internal, external & 3rd party audits.
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.
Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.
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.
Performs technical support of QA Systems.
Develops, analyze, trend, maintains & reports department metrics, as needed.
Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
Reviews and assesses change control, validation, and qualification documents, as applicable.
Creates & approves Master Lot protocols, regulatory protocols & provide technical review for validations
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.