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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
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Details

Quality Assurance Manager


Reference:JCAO1111 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Quality Assurance Manager



Our client a high potential start up currently seeking a Quality Manager to join their team. The Quality Assurance Manager will be responsible for the maintenance of the quality management system (QMS), management of internal processes and external vendors to ensure product quality, helping with regulatory submissions and annual reporting to the notified body and FDA. The person in this position must have broad and deep working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate.


Role/Responsibilities:

  • Maintaining the effectiveness of the QMS and making continuous improvements to it.
  • Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements, cost reduction and new product development.
  • Responsible for FDA facility inspections, notified body audits and other audits and inspections as required
  • Manage the migration from MDD to MDR within the organisation.
  • Maintain and coordinate quality system schedules, including:
    • Supplier and internal audits;
    • management review and;
    • documentation updates.

  • Responsible for production lot release within the organisation.
  • Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
  • Work with the organisation’s suppliers to ensure the product’s process validations and risk management files are to the standard of regulatory submissions.
  • Provide strategic regulatory insight to team members regarding product development plans
  • Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.
  • Maintain the day to day activities of Post Market Surveillance, including, but not limited to:
    • logging customer complaints and adverse events
    • coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required;
    • follow up corrective actions, when required and;
    • compiling data for trend analysis.
    • Performing proactive searches for data including customer surveys

  • Monitor global regulatory trends and requirements impacting the development and commercialization of products, and advise colleagues and external partners to ensure compliance.
  • Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
  • Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
  • Keep abreast of changes in domestic and international Quality Systems regulations and guidelines, and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.
  • Carry out other regulatory and quality related duties as required.
  • Support the Clinical/Regulatory department with CE mark Submissions / Significant Changes and Notified Body interactions.
  • Support the Clinical/Regulatory department with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.




Skills/Experience:

  • Bachelor’s degree in engineering or science. Quality / Regulatory certifications desirable.
  • A minimum of 10 years of experience in a medical device QA position preferably as a QA Engineer or QA Manager. Supervisory experience preferred.
  • Thorough understanding and knowledge of FDA Quality System regulation, ISO 13485 and 21CFR820, ISO 14971, MDD, MDR. Proven track record in writing major regulatory device submissions (i.e. CE certification, IDEs and 510(k)s), with the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies
  • Previous domestic/international submissions experience.
  • Qualified as internal and external auditor
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self-motivated and detailed oriented
  • Excellent oral and written communication skills




For further information please contact James Cassidy [email protected] or call in confidence 0860204322