Senior QA Specialist, Medical Diagnostics & CAPA
Grifols, S.A
Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.
Benefits offered by this job
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
Education
Tools
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.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
