Director, Global Quality - HealthTech

General Overview

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

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

Reporting to Celestica's Vice President of Global Quality, the Director, Global Quality for Health Tech is responsible for the global Health Tech quality team to establish and maintain a quality-first cultureacross 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 andcareer growth opportunities.

Significant experience with FDA certification processes is required.

The Director, Global Quality for Health Tech will be a strategic visionary with a strong operationalbackground, a customer-centric approach, and a proven ability to deliver results. This individual willbe an accomplished and strong leader with excellent communication and interpersonal skills, able toquickly 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.

• 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

• 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 Health Tech teams and host quality forums for issue discussion, decision-making, and plan execution.
• Establish the Health Tech 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 cross functional 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.

• 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%+).

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

• 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 Health Tech industry.
• Global and multi-site leadership experience.
• Experience in driving cultural change for quality awareness.

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

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 jurisdiction of the successful candidate. Salary Range: $161k-252k Annually

Celestica provides eligible employees (those who are scheduled to work 30 hours or more per week) with a range of benefits including medical insurance, dental insurance, vision insurance, short and long term disability, life insurance, voluntary benefits and a 401k plan with company match.

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.

All qualified applicants…