A fantastic opportunity to work as part of a well-established medical device manufacturing company in the Midlands, this is a permanent position available for an immediate start. As part of the compliance team in the Quality department, you will be reporting to the QA Compliance Supervisor. You will be responsible for efficient investigation and reporting of customer complaints of products manufactured and marketed by the company.
- Customer complaint investigations; including DHR review, trend analysis, and failure analysis reports, and risk management review.
- Trending of complaint data and reporting to management. Provision of trend data as requested to support Quality Management Review, corrective action request, and CAPA.
- Maintenance of the complaint database to be audit-ready at all times.
- Work as part of the customer complaint investigation team & liaising with cross-functional teams of multi-disciplines for complaint investigations including external complaint investigation sites.
- Liaising with ILS Key Corporate Teams to support compliance activities.
- Documentation management, including maintenance of Book of Defects, Risk Management Files, and issue suitable Quality Alerts where appropriate.
- Carry out other tasks or responsibilities as directed by Senior Management.
- Ability to work with cross-functional teams in a lead role to support the resolution of product failures.
Qualifications / Experience:
- A minimum of level 6 qualification in an Engineering, Technical or Science discipline.
- Experience working within a regulated Industry with MDSAP / EUMDR program knowledge, along with exposure to other regulations.
- Strong Problem-solving skills for developing creative solutions and meeting objectives are required.
- Experience in preparing reports and reporting out to senior levels in an organisation.
- Demonstrated understanding of the criticality of attention to detail, data accuracy and document control and ability to deliver to deadlines.
- Must have the ability to communicate effectively with management and fellow peers.
- Experience in Six Sigma / lean techniques and statistical analysis.
- Experience of Risk Management Systems & regulating bodies eg. MDSAP /EUMDR
- Ability to accurately scope projects and consider the full impact of decisions and actions taken.
- Relevant experience in a similar role
For a confidential discussion about this opportunity please contact Ranait Coughlan
(090) 6450664 (01) 66 200 88