Senior Manager, Global Quality – Health Tech
Celestica
Healthtech Quality System Manager
Celestica
full-time
Posted on:
Location Type: Office
Location: Galway • 🇮🇪 Ireland
Visit company websiteJob Level
SeniorLead
About the role
- Lead our quality assurance team as a Quality System Manager.
- 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.
- Ensure 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 site's 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).
Requirements
- 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.
- 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.
- Degree qualifications (NQF L8 or L9) minimum in a related field.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality management systems8D reportingquality improvement programsregulatory submissionaudit managementquality strategy developmentmetrics definitioncompliance auditingregulatory affairsquality assurance
Soft skills
leadershipcommunicationmentoringtrainingrelationship managementteam managementcross-functional collaborationperformance improvementcustomer focusorganizational skills
Certifications
CQARAC