ABOUT THE ROLE
Reporting to the Quality Manager within Armstrong Medical, this is an exciting opportunity to support the quality department and work closely with various functions.
Working in close partnership across all functions of Operations to ensure all quality requirements are in place for all products. Reviewing and improving our systems within the Coleraine plant implementing change where appropriate and ensuring compliance with the Quality Management System. This role will suit an individual who can quickly build professional working relationships, works well as part of a team and can investigate and implement improvement activities.
- Oversee the work activity and performance of assigned Quality department staff.
- Co-ordinate QMS outputs/needs effectively with other departmental management and staff.
- Input to regular risk management activities including performing product-related risk analysis.
- Manage and review process validation activities.
- Non-Conformance/Corrective Action/Service Issue Coordinator / Administrator; initiates as required and maintains related documentation; supports owners through the stages of the investigation/report and ensures appropriate actions achieved.
- Perform identification and traceability assessments (product traces).
- Review the effectiveness of all production quality controls (continual improvement).
- Internal auditor recruitment and mentoring.
- Oversight and maintenance of the Internal Auditing program
- Support the Quality Manager in generating complaint Level 1-3 investigations and report-writing.
- Perform measurement, analysis, trending and reporting of Quality data.
- Support the Quality Manager in coordinating retrieval of customer feedback and satisfaction monitoring and subsequent analysis.
- Input to QMS administration and procedures including:
- preparation of QMS reports.
- review and update of Operating Procedures, Quality Forms and Work Instructions.
- Assist Quality Manager with process and product improvement projects and with new supplier contacts.
- Ensure that QMS requirements for product improvement/development analysis work are completed in line with internal QMS requirements and that any such requirements, if applicable, are documented for inclusion in product Technical Files.
- Support the Quality Manager in arranging any QMS data needed for design/change control projects.
- Support the Quality Manager by taking the lead in any QMS requirements for product/materials change control process.
- Liaise with QA staff on product stability testing.
- Contribute to the review of marketing literature/IFU for Armstrong Medical products.
- A degree or equivalent qualification in an engineering, scientific or related discipline.
- Proven experience in a similar role in an ISO regulated manufacturing environment.
- Experience of using problem solving and root cause analysis tools.
- Experience of coordinating and developing Quality Management System (QMS) requirements in a regulated industry.
- Internal auditor experience
- Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer/audit issues.
- Excellent communication and interpersonal skills with ability to quickly build effective professional working relationships.
- Experience in a medical device/pharmaceutical/life sciences environment
- Knowledge of the maintenance of QMS in association with medical devices e.g., ISO13485, MDD, EU MDR, MDSAP
- Experience in use of statistical analysis software
- ISO13485 Quality auditing certification and coordinating internal audit programmes.
- Experience of using lean manufacturing / improvement tools e.g., 5S, Six Sigma.
- Process Validation design and implementation.
- Experience of Risk Management techniques compliant with ISO 14971.
KEY WORKING RELATIONSHIPS
- Departmental managers
- Production – to liaise with production personnel at all levels to ensure requirements for quality are defined and met. Develop, implement and maintain appropriate quality metrics.
- Regulatory – to work with regulatory personnel to ensure compliance is maintained, with a focus regarding compliance reports for various standards.
- Employees at all levels.
- Notified bodies during audits.
- Dealing with customers and third-party auditors during quality audits
- Dealing with suppliers and sub-contractors to discuss quality related issues and improvements.
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and does not dwell on past events.
Team Working – Enjoys participating in group activities and likes to work in proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail.
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively.
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with others in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Does not give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease. Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.