Specialist, Complaints, Quality

About the role

West Pharmaceutical Services is hiring a Specialist, Complaints, Quality in Dublin. The role ensures internal system compliance and conformity with customer specifications, supporting complaint handling and regulatory reporting so that internal and external complaints are closed out in a timely and effective way. It is a hybrid position with three days per week onsite, and no relocation assistance is provided.

Key responsibilities

• Coordinate and support the handling of product complaints received by customers, keeping records and entering data into the complaint handling system
• Work with customers to communicate requirements and concerns, and close corrective and preventive actions
• Review medical device complaints under the DHR within the QMS and lead investigations into customer, material and product issues to implement root cause, containment and CAPA
• Assess the adequacy of complaint information from the field and support complaint trend analysis and key reports
• Support risk management, risk analysis and health hazard analysis linked to post-market information, and respond to Competent Authority queries
• Ensure compliance with internal procedures and global regulatory requirements, run internal audits, manage quality projects such as Lean projects and coach a culture of compliance

Required profile

• Third-level qualification in Engineering, Quality or Science
• 2+ years of work experience in a medical device manufacturing environment
• Excellent oral and written communication skills
• Team player able to work proactively on cross-functional teams
• Experience with complaint handling or CAPA processes is desirable

Required skills

• Working knowledge of quality systems such as ISO 13485 is essential
• Experience of 21 CFR Part 820 and EU GMP is an advantage
• Auditing experience to ISO 13485 / EU GMP / 21 CFR Part 820 is preferred

What we offer

• Annual base salary range of EUR 48,000 to EUR 61,100, with possible variable compensation and incentive programs
• Training, tuition assistance, leadership development and skill certification
• International career opportunities across North America, Europe and Asia-Pacific
• Volunteerism through the West without Borders initiative and other charitable programs