Homeoffice Senior Director, Global Quality - HealthTech (Maple Grove, MN, US) presso Celestica
Celestica · Maple Grove, Stati Uniti d'America · Remote
- Senior
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 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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Celestica's policy on equal employment opportunity prohibits discrimination based on race, color, creed, religion, national origin, gender, sexual orientation, gender identity, age, marital status, veteran or disability status, or other characteristics protected by law.
This policy applies to hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral and other aspects of employment and also states that retaliation against a person who files a charge of discrimination, participates in a discrimination proceeding, or otherwise opposes an unlawful employment practice will not be tolerated. All information will be kept confidential according to EEO guidelines.
COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
This location is a US ITAR facility and these positions will involve the release of export controlled goods either directly to employees or through the employee's movement within the facility. As such, Celestica will require necessary information from all applicants upon an applicant's acceptance of employment to determine if any export control exemptions or licenses must be filed.
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