Senior NPI Quality Leader - DFx, QMS & Launch

Bo Growth; Valencia; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Celestica seeks a Senior Quality Manager focused on New Production Introduction (NPI) to lead QMS deployment, DFx reviews, and validation strategies across HealthTech sites. You will drive launch readiness, customer surveys, and regulatory compliance, coordinating with global teams to ensure quality excellence.

The role requires over 15 years in Quality Management, with expertise in ISO13485, 21 CFR 820, and change control.

Qualifikationen

• Expert knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.
• Deep proficiency in defining critical quality processes, tools, and system applications for site-level and customer-specific objectives.
• Mastery of core quality methodologies (FMEA, 8D, CCB, MQS).
• Technical understanding of IQ/OQ/PQ validation and DFx for smooth design-to-mass production transitions.
• Ability to assess quality data to establish metrics, targets and improvements.

Aufgaben

• Lead the design and deployment of QMS processes and tools for NPI objectives and customer requirements.
• Drive DFx reviews and oversee validation strategies (IQ/OQ/PQ).
• Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys.
• Ensure conformance to international regulations and customer certifications (ISO 13485, ANSI/ESD).
• Analyze data from customer scorecards and regulatory audits to communicate action plans to stakeholders.
• Develop and support key QMS processes to ensure regulatory compliance and mitigate risks.
• Document and deploy global quality processes (Audit Compliance, Customer Feedback).
• Educate sites on global procedures to build independent quality teams.

Kenntnisse

Quality Frameworks

NPI Quality Planning

Advanced Quality Tools

Validation & DFx

Performance Analytics

Ausbildung

Bachelor's degree or higher in Engineering or Quality Management

Industry certifications (ASQ, Six Sigma, ISO13485 Lead Auditor)

Jobbeschreibung

Celestica seeks a Senior Quality Manager focused on New Production Introduction (NPI) to lead QMS deployment, DFx reviews, and validation strategies across HealthTech sites. You will drive launch readiness, customer surveys, and regulatory compliance, coordinating with global teams to ensure quality excellence.

The role requires over 15 years in Quality Management, with expertise in ISO13485, 21 CFR 820, and change control.