Senior Manufacturing Quality Engineer
1 week ago
Grifols is seeking a highly skilled Senior Manufacturing Quality Engineer to join our team in San Diego, CA. As a key member of our Operations department, you will be responsible for driving quality excellence and regulatory compliance across all aspects of our manufacturing processes.
Key Responsibilities:- Lead Quality Engineering support to address issues and implement improvements within the Operations and Quality departments.
- Independently write complex technical documentation, including change controls, protocols, test plans, quality specifications, and reports.
- Perform review, approval, and assessment of validations, DMRs, change orders, protocols, and reports.
- Own and author nonconformance and CAPA records.
- Independently conduct investigations, root cause analysis, and risk assessments.
- Proactively identify and lead process improvement opportunities and projects.
- Independently conduct data analysis and create/improve metrics.
- Identify and drive actions based on data.
- Lead complex projects and drive action plans to meet timelines.
- Present results to upper management.
- Make quality decisions based on data to address complex issues.
- Escalate issues when needed.
- Proactively provide routine on-the-floor support to Operations.
- Analyze manufacturing processes and drive the implementation of quality improvements.
- Participate in Core Teams as the lead Quality representative.
- Author process FMEAs for critical manufacturing processes.
- Work closely with Supplier Quality team to identify and resolve supplier quality issues.
- Represent Production Quality department as the subject matter expert during audits/inspections.
- Ensure compliance to regulatory standards and high-quality products are manufactured.
- Complete training in a timely manner and maintain training record.
- Conduct training sessions as needed (GMP, QMS, Quality Issues, etc.).
- Assist in validations and troubleshooting activities, as needed.
- Update/create procedures, forms, work instructions, etc. to standardize and improve processes.
- Mentor junior department personnel.
- Act as backup to department manager, as needed.
- Excellent writing skills, including independently writing SOPs, forms, and risk assessments.
- Strong technical writing skills.
- Excellent presentation skills, including independently preparing, organizing, and presenting information based on the audience.
- Strong knowledge of manufacturing processes (bulk formulation, filling, packaging, etc.).
- Strong communication skills with an ability to convey ideas clearly to all levels within a cross-functional team.
- Proficient in Microsoft Office Suite.
- Knowledge of Good Manufacturing Practices (GMP).
- Willing to work collaboratively to identify and implement a sustainable solution.
- Strong attention to detail and ability to analyze data using statistical software.
- Strong project management and organizational skills with the ability to work on multiple projects with competing deadlines.
- Ability to train and mentor within and outside the group.
- Advanced knowledge of production requirements under ISO 13485 and 21 CFR standards.
- Quality certification (from American Society for Quality or equivalent).
- At least 10 years of prior experience in the Medical Device industry in a production environment.
- At least 3 years of prior experience leading and/or performing investigations.
- Prior experience implementing process improvements.
- Prior experience working with SAP.
- Competitive salary range: $122,268.00 to $152,835.00 per year.
- Eligibility to participate in up to 15% of the company bonus pool.
- A wide variety of benefits, including medical, dental, vision, PTO, up to 5% 401(K) match, and tuition reimbursement.
Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. We are committed to offering our employees opportunities for professional growth and career progression.
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