Senior QA Specialist, Medical Diagnostics & CAPA

Grifols, S.A; San Diego (CA); On-site; USD 108,026 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

401(K) match

Tuition reimbursement

Job summary

Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist to manage nonconformances, CAPAs, and OOT reports while driving quality improvements. The role involves audits, risk assessments, training, and mentoring staff in a fast-paced biotech setting in San Diego, CA.

Candidates should have a BA/BS in biology/chemistry/biochemistry or biomedical engineering, with 5–8 years of quality experience (or 3–6 years with a Master’s) and may hold ASQ certification.

Qualifications

• BA/BS in biology, chemistry, biochemistry or biomedical engineering.
• Quality certification from ASQ or equivalent is a plus.
• 5–8 years of related quality experience (or 3–6 years with a Master’s).

Responsibilities

• Investigate instrument-related complaints, document findings and trend data.
• Review, update and create SOPs to standardize investigations.
• Apply regulatory knowledge to identify reportable events and support actions.
• Lead cross-functional teams to drive product quality improvements.
• Represent QA on special projects and coordinate regional meetings.
• Interact with regulators/auditors and mentor junior staff.

Skills

Complaint handling

Nucleic acid testing instrument

Quality control

Manufacturing & Inventory processes

SAP

Salesforce

Microsoft Word

Excel

PowerPoint

Education

BA/BS in biology/chemistry/biochemistry/biomedical engineering

Tools

SAP

Salesforce

Microsoft Word

Excel

PowerPoint

Job description

Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist to manage nonconformances, CAPAs, and OOT reports while driving quality improvements. The role involves audits, risk assessments, training, and mentoring staff in a fast-paced biotech setting in San Diego, CA.

Candidates should have a BA/BS in biology/chemistry/biochemistry or biomedical engineering, with 5–8 years of quality experience (or 3–6 years with a Master’s) and may hold ASQ certification.