Reporting to the Quality Engineering Manager within Operations this role ensures internal system compliance and customer specifications conformity. Complaint Reporting Specialist to support complaint handling and regulatory reporting activities. This role will ensure the timely and effective closure of internal/external complaint handling.
Job Type: Full Time Permanent Location: Dublin Salary: 50-53k DOE
Must have a third level qualification in Engineering/Quality/Science.
Must have 2+ years work experience in a Medical Device manufacturing environment.
A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
Team player who can work effectively and proactively on cross-functional teams.
Experience/understanding of complaint handling or CAPA processes are desirable
Must have excellent communication skills both oral and written.
Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
Essential Duties and Responsibilities:
To coordinate and support complaint handling of product complaints received by customer
Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
To open, track and maintain records for complaints received by customers.
Data entry into complaint handling system.
DHR review of Medical Device to be conducted within the QMS
Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
Support complaint trend analysis and issuance of key reports to relevant departments.
Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
Support responses to Competent Authority queries.
Understand and ensure compliance with internal procedures and external global regulatory requirements.
Develop processes and systems in line with best industry practice.
Executing internal process and system audits.
Manage quality projects in support of continuous improvement eg. Lean Projects.
Ensuring the timely and effective closure of day-to-day complaints issues.
Interface with other departments on a daily basis.
Coach and drive a culture of compliance and continuous improvement.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all site Environmental, Health and Safety requirements, training and regulations.
Compliance to all local site company policies, procedures and corporate policies.
For more information, please apply through the link provided for the attention of Daniel Kirwan or email [email protected] If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided Please submit your updated CV in Word Format If you are living in Ireland and hold a valid work permit, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer.