Overview In this role, you will ensure manufacturing operations meet GMP and regulatory standards while driving quality improvements. You'll work within a cross-functional team to resolve quality issues, lead CAPA and process validation activities, and implement Lean QMS initiatives. You will influence supplier quality, product quality, and customer satisfaction through rigorous documentation and issue resolution. This is a hands-on position where your contributions help eliminate escapes and reduce waste while upholding Nordson Medical's quality culture.
Responsibilities- Ensure adherence to GMP, GDP, ISO 13485, and 21 CFR Part 820 across manufacturing operations
- Lead root-cause analysis, CAPA investigations, and verification of effectiveness
- Design, execute, and document gage R&R studies
- Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs)
- Lead process improvement events to reduce COPQ and scrap in multiple product lines
- Qualify as Quality Representative for Material Review Board (purchased and make components)
- Manage SCAR process including issuance, supplier notification, approval, and effectiveness review
- Investigate and respond to customer complaints and customer-issued SCARs
- Represent Quality in Process Validations and Transfer Validations (writing/reviewing/executing/reporting protocols)
- Prepare quality deliverables and execute engineering studies as needed
- Own CAPA root-cause investigations and corrective actions
- Implement SPC and drive zero escapes to customers
- Create control plans and support KPI achievement and quality deliverables
- Support Quality Culture and Lean QMS initiatives to remove bureaucratic waste
- Participate in Quality and Manufacturing department meetings
- Clarify specifications for quality and act as a technical consultant
- Support supplier management as required and participate in internal audit activities
- Follow medical device manufacturing best practices and Nordson policies and applicable regulations
Key requirements- GMP/GDP/ISO 13485/21 CFR Part 820 knowledge
- CAPA, root-cause analysis and corrective actions
- Process Validation and Transfer Validation experience
- SCAR and MRB involvement
- Gage R&R design and analysis
- Strong documentation and quality deliverables
- Supplier quality and internal audit exposure
- Lean/QMS process improvement exposure
- Cross-functional collaboration and consulting in quality matters
- Ability to meet KPI goals and drive quality metrics
- collaborative mindset
- problem-solving
- effective communication
- Gage R&R studies
- CAPA investigations and effectiveness verification
- Process Validation/Transfer Validation
