Senior Director, Global Quality - HealthTech

Req ID: 128635 
Region: Americas 
Country: USA 
State/Province: Minnesota 
City:  Maple Grove 

General Overview

Functional Area:  Quality (QUA)
Career Stream:  Global Quality (GLQ)
Role:  Director 2 (DR2)
Job Title:  Director, Global Quality 2
Job Code:  DR2-QUA-GLQ
Job Level:  Level 13
Direct/Indirect Indicator:  Indirect

Summary

Reporting to Celestica's Vice President of Global Quality, the Director, Global Quality for HealthTech is responsible for the global HealthTech quality team to establish and maintain a quality-first culture across worldwide manufacturing facilities. This involves managing a large global organization, collaborating with customers, suppliers, and partners, and ensuring compliance with regulatory requirements (FDA, ISO, ASQ, RAC). The position is virtual, offering competitive compensation and career growth opportunities. Significant experience with FDA certification processes is required.

Candidate Profile
The Director, Global Quality for HealthTech will be a strategic visionary with a strong operational background, a customer-centric approach, and a proven ability to deliver results. This individual will be an accomplished and strong leader with excellent communication and interpersonal skills, able to quickly establish and maintain strong cross-functional relationships with key stakeholders. The successful candidate will have a proven history of driving operational excellence and achieving business goals in a complex and dynamic environment.

Key Relationships:
- Reports to: Vice President, Global Quality
- Reports:  Dotted line reporting ~8 sites (each site with a quality manager) ~51 Indirect Labor

- Key relationships 

• Operations Leadership Team
• Site General Managers and Operation Leaders
• Global Business Unit General Managers and Leaders
• Customer stakeholders

 

Detailed Description

Responsibilities:
● Develop and implement the global quality strategy in collaboration with regional and site
leadership, identifying gaps and creating short and long-term plans.
● Share best practices across HealthTech teams and host quality forums for issue discussion,
decision-making, and plan execution.
● Establish the HealthTech Quality Strategy (e.g., MDSAP / MDR).
● Define annual quality objectives and metrics aligned with business priorities, driving quality
culture and performance improvements.
● Oversee the quality management system globally, including industry certifications, customer
surveys, operational reviews, and system applications.
● Cultivate an "audit-ready" culture and direct the Global Regulatory Compliance Audit
Program, ensuring internal audits are effective and findings are tracked to closure.
● Conduct Quality Management Reviews and training with manufacturing sites and executive
management, advising on risks and mitigation plans.
● Maintain an effective 8D reporting system for quality issues and resolutions, involving crossfunctional staff.
● Manage talent within the Quality team, including hiring and training.
● Provide program management leadership for special projects and initiatives and guide
quality communities and internal teams.

Knowledge/Skills/Competencies

● Strong relationship management and interpersonal skills.
● Proficiency in Microsoft Office for data analysis and reporting.
● Understanding of validation principles and testing procedures.
● Knowledge of FDA, ISO, RAC, and CQA regulations and standards.
● Willingness to travel internationally (60%+).

Physical Demands

 

• Incumbent will perform the duties of this position in a normal office environment.
• Occasional overnight travel is required.

Typical Experience

● 10-12 years in quality management and related functions (Manufacturing Quality, Design
Quality, Validation, Quality Assurance, Quality Systems).
● Minimum 5 years conducting quality audits.
● Experience with FDA and regulatory inspections.
● In-depth knowledge of quality management systems and global compliance.
● Experience in the HealthTech industry.
● Global and multi-site leadership experience.
● Experience in driving cultural change for quality awareness

Typical Education

● Degree in Engineering or Sciences required.
● RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification is desirable

Salary Expectations and Benefits Summary

The salary range described in this posting is an estimate by the Company, and may change based on several factors, including by not limited to a change in the duties covered by the job posting, or the credentials, experience or geographic juris