Senior Quality Engineer QA Complaints @ GRIFOLS, S.A.
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About GRIFOLS, S.A.
Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that since 1909 has been dedicated to enhancing the lives of millions worldwide through plasma-derived medicines, transfusion medicine, and innovative healthcare solutions.
About the Senior Quality Engineer QA Complaints Role
The Senior Quality Engineer QA Complaints independently writes complex investigations for Hardware, Software, and System level complaints. This role involves data trending, preparing periodic reports, reviewing/updating/creating SOPs, leading CAPA actions, and acting as a Subject Matter Expert during audits, all while coordinating cross-functional teams and managing complaints investigations.
Primary Responsibilities
- Draft complex investigation reports and finalize complaint investigations.
- Coordinate with customers, field service, R&D, and vendors.
- Perform data trending and prepare periodic quality reports.
- Review, update, and create SOPs to improve investigation processes.
- Lead CAPA actions and support audit processes as an SME.
- Coordinate regional calls and Product Quality Committee meetings.
- Support MDR/Adverse Events reporting and conduct risk assessments.
Required Skills and Experience
The role requires excellent writing and presentation skills for investigation reports and SOPs, advanced proficiency with SAP, Salesforce, Excel, Word and PowerPoint, and strong organizational and analytical abilities. Knowledge of GMPs, medical device regulations, and cross-functional teamwork is essential. A Bachelor’s degree in biomedical engineering and at least 8 years of related experience are required.
Additional Information
This role is based in San Diego, CA and offers a competitive salary of approximately 147,000 USD per year, with eligibility for up to 15% bonus and comprehensive benefits including medical, dental, vision, PTO, 401(K) match, and tuition reimbursement.
Key skills/competency
- Investigation
- CAPA
- Audit
- SOP
- Data Trending
- Complaint Analysis
- Healthcare
- GMP
- Risk Assessment
- Team Coordination
How to Get Hired at GRIFOLS, S.A.
🎯 Tips for Getting Hired
- Customize your resume: Highlight relevant complaint investigation skills.
- Research GRIFOLS, S.A.: Understand their history and mission.
- Emphasize technical expertise: Include SAP, Excel, and auditing skills.
- Prepare for behavioral questions: Focus on teamwork and problem solving.