Sr Quality Assurance Specialist

Grifols•San Diego, CA

5d•Onsite

About The Position

Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist. The Sr Quality Assurance Specialist manages nonconformances, Out-of-Tolerance Reports, and CAPA records, ensuring timely corrective actions and comprehensive documentation. They lead quality meetings, represent QA in daily meetings, and drive quality improvements through operational analysis and compliance audits. The role involves improving procedures, conducting risk assessments, preparing for audits, managing metrics, mentoring junior staff, and developing training programs. Additionally, they review and approve manufacturing documents, lead projects, make data-driven decisions, facilitate training sessions, and act as a backup to the department Supervisor/Manager.

Requirements

At least a BA or BS in biology, chemistry, biochemistry or biomedical engineering.
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.
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.
Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.
Ability to train and mentor within and outside the group

Nice To Haves

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

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.
Independently conducts instrument related complaint investigation (nucleic acid testing) through interfacing with field reps. to acknowledge, document and obtain detailed information/returns regarding complaints, performing deeper investigation into root causes, assigning additional actions as necessary to close the complaint, performing data trending and preparing periodic reports relating to complaints and quality issues.
Review/update/create SOPs to standardize the investigation process.
Applies knowledge of medical device regulatory requirements to identify reportable events as they are received, support the reporting decision process, and coordinate Product Quality Committee meeting to determine appropriate plans for actions to be taken.
Provide track and trending for PHSC.
Leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements.
Ensures implementation/sustainability and monitors the field quality of the improvements.
Represents QA interests on special projects related to area of expertise.
Coordinates regional meetings with field service engineers and field service representatives.
Interacts with regulatory and partner auditors/inspectors.