|Head of Quality medical devices N. Irl|
Leads the factory QA/QC Team managing overall execution to quality processes at manufacturing facility in partnership with Manufacturing and Engineering. The Head of Quality will play an integral role in interpreting regulations and standards into company policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS areas of responsibility. Will have responsibility for Product Quality support through all phases of production support and improve various quality system processes to maintain regulatory compliance.
- Oversee Operations/Manufacturing QA/QC and their leadership, calibration, receiving quality assurance (RQA), and other operations quality functions as required.
- Operations Quality areas of ownership, management, and responsibility may include (as assigned): Incoming product testing, QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non-conformance investigation and controls, Product Release, Supplier management, CAPA, Audit (internal, external, supplier), Quality System Training, Document Control, Management Review, etc.
- Responsible as Legal Manufacturer, as appropriate, for specific products (as applicable).
- Support manufacturing to produce products, improve product and process quality through the use of quality management techniques, such as First Time Quality (FTQ) initiatives; identify and drive improvement projects to either gain efficiency, improve product quality or cost down.
- Oversee and manage NC process and root cause investigation. Work with cross functional team to drive improvements to reduce NCs.
- Oversee and manage the throughput and backlog of inventory in incoming and final inspections, and staff/schedule accordingly.
- Partner with Supply Chain function to monitor and manage quality across supply chain.
- Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
- Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective.
- Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
- Monitors the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
- Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
- Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
- Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
- During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
- Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.
- Ensure that the Quality system is updated and maintained to the current GMP as required by European and American regulatory authorities, ISO 9001, and ISO 13485 and MDSAP (as applicable).
- At minimum, Degree in a Life Science – or a closely related subject.
- Minimum 5 years’ experience in a similar senior role within a Medical Device, Pharmaceutical Manufacturing or relevant Regulatory field.
- Minimum 5 years’ experience in Document Control, Risk Assessment within a Medical Device, Pharmaceutical Manufacturing or relevant Regulatory field.
- Strong Management Skills
- Preferred training in FDA Quality System Regulation and ISO 13485.
- Experienced in leading audit responses to various notified bodies.
- Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485).
- Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, QA/QC personnel, and management.
- Scientific problem-solving skills using industry accepted tools such as DMAIC, KT Analysis, or equivalent.
- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
- Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
- Ability to work collaboratively across functions and cultures.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
- Must be detail oriented, well organized and able to work independently and in teams.
- Demonstrated ability to lead people and get results through others.
- Lead Auditor to ISO 13485 2016 Standard
- Training/Experience in FDA Quality System Regulation
- AQL Certification, formal LEAN manufacturing training and/or Six Sigma
- Higher Degree or qualification in Quality Systems
- Membership of a recognized Quality Organisation
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