Senior Manager, Global Quality for HealthTech
The Senior Manager, Global Quality for HealthTech is responsible for the global HealthTech quality team in Celestica Galway 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). Significant experience with FDA certification processes is required.
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 / EU 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 (15%+).
Education:
* Degree in Engineering or Sciences required.
* RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification is desirable.
* 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.
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.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
Information on Personal Data Protection:
Thank you for sending your CV/job application. CELESTICA IRELAND LIMITED., with 999925 and with address for notification purposes at Parkmore Business Park West, Ballybrit, Galway, confirms receipt of your job application and/or CV and informs you that the personal data provided by you when sending us your CV will be processed exclusively for the purpose of including you in our internal employment database, and, where appropriate, to participate in possible personnel selection processes.
We also inform you that we will keep your personal data for a maximum period of one (1) year and that you may exercise your right of access, rectification, cancellation, opposition, suppression, limitation or portability. To exercise any of these rights, you must do so in writing addressed to privacy@celestica.com, enclosing a copy of your ID card or equivalent document, to enable us to identify you correctly.
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.
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