Senior Manufacturing Quality Engineer

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary

The Senior Manufacturing Quality Engineer is responsible for driving quality excllence and regulatory compliance across all aspects of Operations.  They will lead a range of responsibilities and projects related to Nonconformance/CAPA, Risk Management, Root Cause Analysis, Product Release, Quality Inspection, and Change Control activities. 

 

Primary responsibilities for role:

• Lead Quality Engineering support to address issues and implement improvements within the Operations and Quality departments.
• Independently write complex technical documentation such change controls, protocols, test plans, quality specifications and reports.
•  Perform review/approval/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.  
• Particpate 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.

 

Knowledge, Skills, and Abilities

• Excellent writing skills, including independently writing SOPs, forms, and risk assessments. Must be a strong technical writer.
• 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 crossfunctional 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.
• Represents Quality Assurance interests on special projects.
• Ability to train and mentor within and outside the group. Advanced knowledge of production requirments under ISO 13485 and 21 CFR standards

 

Education

Requires bachelors degree(s) in molecular biology, biology, chemistry, biomedical engineering, or a related field.

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

 

Experience

At least 10 years of prior experience in the Medical Device industry in a production environment is required.

At least 3 years of prior experience leading and/or performing investigations is required.

Prior experience implementing process improvements is required.

Prior experience working with SAP is highly perferred.

 

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires