Our client a global healthcare leader based here in Galway City are looking to hire a Quality Lead Customer Service on a fixed-term basis.
The CS Quality Lead will be responsible to plan, manage and implement all quality-related activities within the Customer Service function. This role will work closely with the Quality department and represent CS in all internal and external Quality audits. This role will also empower and lead all Customer Service staff to operate in a way that ensure compliance across all tasks and ensures that we are audit-ready all year round. This will be achieved through the management of (1) Quality and compliance adherence in all activities, (2) Training, (3) Customer Feedback management, (4) Process improvement management and (5) Management of all Capa’s and Qi management and compliance of KPI’s on a timely basis.
- Cross alignment between the Customer Service functions (both International and Domestic operations and the new CS Excellence team) and the Quality function.
- Compliance - Understands the Quality Management Systems (QMS) in place, Company Standard Operating Procedures (SOP’s), and Work Instructions (WI’s), and works to ensure that all Customer Service activities are in compliance with established procedures and/or protocols.
- Capa’s and QI’s - Works with all CS staff and related departments to investigate QI’s and Capa’s and then manage the preparation of all functional QI & Capa documentation in Agile in an accurate and timely manner, adhering to timelines for completion at each stage.
- FSN’s - Management and support for any Field Safety notices that need to be issued to customers.
- Periodic reviews - Functional review of SOP’s, WI’s, FMEA’s, and other Documentation with the Quality department to ensure accuracy and alignment with policies, timelines, directives and protocol.
- Reporting - Accurately reports on the status of all of the Quality related activities to the Senior CS manager on weekly basis – so that status tracking on all actions and activities is transparent and measurable.
- Audits - Represents Customer Service in all Quality meetings and Internal and External Audits during the year and is responsible for ensuring that all Customer Service departments and fully prepared in advance of all audits.
- SAP Process Alignment – responsible for ensuring that any SAP testing and any change requests are implemented in a timely manner across the CS team.
- Customer feedback – manage the tracking of Customer Compliments and Complaints across the CS departments in line with the expectations from Quality as a result of new directives.
- Metric alignment – ongoing alignment with the Customer Service managers, Leads, and Team leads to ensure that CS KPI’s are met on an ongoing basis through training and experience.
- Continuously reviewing opportunities to streamline processes and implement Process, IT, or system changes that will drive efficiencies and improve our customers' experience.
- Strong compliance and analytical skills, excellent attention to detail, and good business judgment.
- Effective communicator, both articulate & verbally presentable.
- Excellent interpersonal skills with an ability to achieve results through influencing others and maintaining strong links with other departments.
- Self-starter possesses flexibility and the ability to work under pressure in a fast-changing ambiguous environment.
- Strong record of developing and implementing procedures.
- Positive attitude and team player with a high level of initiative, energy, and enthusiasm.
- Possesses and applies a fundamental and increasing knowledge of Quality, and its application to the completion of routine assignments.
- Works in compliance with established procedures and/or protocols.
- Administration and Organization of documentation relating to preparation and implementation of QI’s and Capa’s including recognizing where escalation points are required.
- Screening incoming requests and progressing where all relevant information is available.
- Maintenance of metrics and updating metrics boards and spreadsheets.
- Continuous improvement - Administration and support of the quality process.
- Minimum 1 years’ experience in medical device industry, including;
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- Competency in conducting review of documentation/ communications.
- Experience in managing customer service teams desirable.
- Demonstrated understanding of working with a Quality system, Standard Operating Procedures and Capa/QI’s documentation and compliance.
- SAP ERP and Agile experience essential.
For a confidential discussion and more information about the role please contact Michelle Mc Inenrey