Req ID: 129954
Remote Position: No
Region: Europe
Country: Ireland
State/Province: Galway
City: Galway

Summary

Lead our quality assurance team as a Quality System Manager. We are hiring a Medical Device expert to own our QMS strategy and ensure flawless global compliance (FDA, ISO). This is a high-impact, mission-critical role based in Galway.

Detailed Description

Our next challenge will be to…

Develop and implement a comprehensive quality strategy aligned with the company’s long-term goals.
Oversee the quality management system for site, including industry certifications
Define annual quality objectives and metrics aligned with business priorities, driving quality culture and performance improvements.
Cultivate an "audit-ready" culture for the site by participating in the Global Regulatory Compliance Audit Program.
Ensuring internal audits are effective and findings are tracked to closure.
Maintain an effective 8D reporting system for quality issues and resolutions, involving cross-functional staff.
Provide program management leadership for special projects and initiatives and guide quality communities and internal teams.
Lead Quality Improvement Programs (QIP) in support of customer requirements and expectations
Direct and influence the preparation of documentation to support high quality regulatory submission dossiers.
Act as the sites primary representative for all quality system related matters, ensuring compliance with QSR, FDA, ISO, and other pertinent regulations
Act as company representative, developing and maintaining positive relationships with the Customer through oral and written communications.
Manage with the customer the submission strategy/regulatory pathway and follow-up of any submissions under review.
Mentors and trains personnel in the practices of Quality management and Quality improvement (succession development)

What do we offer:

Market-competitive total reward: flexible salary, fix and variable salary based on goals
The opportunity to become a key member of the management team in the Health Tech business driven by innovation where creativity matters.
Training and development opportunities, with us the sky is the limit!
The opportunity to innovate, learn, mentor others and work toward your own vision of career success
A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities
A sustainable culture where we provide opportunities for employees to give back to the community.

Knowledge/Skills/Competencies

Strong relationship management and interpersonal skills
In depth knowledge of FDA, ISO, RAC, and CQA regulations and standards.
Experience with FDA and regulatory inspections
In-depth knowledge of quality management systems and global compliance.
Experience in the Medical device industry
Ability to effectively, communicate with a wide variety of internal and external customers.
Ability to effectively lead, manage, train and motivate a diverse group of employees
Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint.

Typical Experience

Minimum of 7-10 years’ experience in a Quality role
2 – 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required.
Working knowledge of FDA and international regulations
Experience working directly with FDA, notified bodies and/or international health authorities is desired.

Typical Education

• Degree qualifications (NQF L8 or L9) minimum in a related field

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.

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.

Healthtech Quality System Manager

Benefits

Job Description