Senior Manufacturing Quality Engineer
2 weeks ago
Grifols is seeking a Senior Manufacturing Quality Engineer to drive quality excellence and regulatory compliance across all aspects of Operations. This role 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.
Key Responsibilities- Lead Quality Engineering support to address issues and implement improvements within the Operations and Quality departments.
- Independently write complex technical documentation such as 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.
- 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.
- 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 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.
- Represents Quality Assurance interests on special projects.
- 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), is a plus.
- 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 preferred.
Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery, and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities.
Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups.
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