Senior Manager Quality Assurance, Instrumentation
Manchester, United Kingdom
- Manage, develop and implement the quality system process for the collection, review and disposition of customer complaints for regulated products manufactured under the responsibility of QIAGEN Instruments;
- Train global QIAGEN employees on the regulated complaint management process, including sales, field service, and other off-site employees;
- Oversight of the CAPA process related to QIAGEN Instrumentation;
- Oversight of Change Control processes related to QIAGEN Instruments, in association with Platform Management teams;
- Interaction with Supplier Quality Assurance team, including involvement with audits of suppliers, subcontracting etc.;
- Lead cross-functional teams to investigate problems, address issues and manage workflow;
- Serve as the key contact for Complaint Management, Vigilance, MDR and Product Performance Investigations related to QIAGEN Instrument during external audits and inspections;
- Establish and maintain quality system links and standard methods of communication with QIAGEN sites globally. Activly contribute into the development of global SOP's in the area of Complaint Management and CAPA;
- Support activities required in the event of field action.
- Working knowledge of cGMP, QSR and ISO regulations/standards relating to IVD instrumentation - in particular, CAPA and complaint handling within a regulated environment;
- Degree (or equivalent work experience) ideally in a science based discipline;
- Experience of participating in/leading regulatory audits;
- Experience in the field of Instrumentation/Engineering an advantage;
- Line Management Experience;
- Must be able to exercise excellent judgement for decision-making responsibilities. Must also be able to prioritize departmental responsibilities in a multi- tasking environment;
- German language skills are advantageous.
- Excellent interpersonal and communication skills and the ability to work with people at all levels;
- Self-motivated, flexible and able to work autonomously.
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