Summary

Senior Quality Manager - New Production Introduction (NPI) Focus

Detailed Description

Quality Planning & Strategy: Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met.
DFx & Technical Readiness: Drive Design for Excellence (DFx) reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production.
Launch Readiness: Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.
Regulatory Oversight: Ensure site-wide conformance to international regulations and customer certifications (e.g., ISO 13485, ANSI/ESD).
Performance Monitoring: Analyze data from customer scorecards, regulatory audits, and operational performance to identify gaps and communicate action plans to stakeholders.
Global QMS process ownership: Develop and support key QMS processes to ensure regulatory compliance and mitigate operational risks.
Process Deployment: Document and deploy global quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives.
Training & Capability Building: Educate sites on global procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives.

Knowledge/Skills/Competencies

Quality Frameworks: Expert-level knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.
NPI Quality Planning: Deep proficiency in defining critical quality business processes, tools, and system applications required to meet site-level and customer-specific quality objectives.
Advanced Quality Tools: Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols, and Manufacturing Quality Standards (MQS).
Validation & DFx: Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure seamless transitions from design to mass production.
Performance Analytics: Ability to assess quality performance data to establish metrics, targets, and improvement strategies (e.g., Monthly Operations Reviews, Quality Excursion Reporting).

Typical Experience

15+ years of progressive experience in Quality Management, with a proven track record in NPI, manufacturing scale-up, and global QMS deployment.

Typical Education

Bachelor's Degree or higher in Engineering, Quality Management or a related technical field.
Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

Global Quality Senior Manager - NPI