Overview
Quality Manager Jobs in County Offaly, Ireland at Inova Group
Title: Quality Manager
Company: Inova Group
Location: County Offaly, Ireland
Recruiting a Quality Manager for a leading pharmaceutical group in the midlands:
Reporting to the Operations Director, and with a dotted line to Director of Quality Europe, the Quality Manager is responsible to lead and manage a group of Quality professionals to ensure a high level of Quality Management Systems and regulatory compliance in the plant.
The Quality Manager will work alongside all other members of the Site Leadership Team to achieve the site’s key performance metrics and deliver its strategic objectives.
- Manage and develop the Quality team against agreed targets and budgets according to company standards, policies and procedures (appraisals, discipline, training, development, etc.).
- Develop and implement Quality Management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation’s annual business plan and long-term strategy.
- Develop, sustain and continuously improve the QMS in accordance with Company procedures and regulatory requirements. (ISO 13485, FDA 21 CFR Part 820, GMP/GDP, Customer Codes of Practice)
- Identify and manage the Quality Budget, ensuring the reduction in risk from claims and all potential costs.
- Act as site Management Representative responsible for the planning and execution of Management Review activities, including tracking and closure of action items.
- Responsible for the timely processing and closure of customer feedback through the QMS Complaint process, escalating critical issues as appropriate.
- Drive robust timely and effective corrective and preventive action programs through the CAPA system ensuring the use of appropriate problem-solving tools.
- Develop and maintain internal audit program, lead and support third party audit.
- Ensure compliance to Change control requirements, leading collaboratively and driving documented and timely change control within QMS.
- Identify, develop, and report QMS trending, metrics and KPIs. Enabling the Clara leadership team to have oversight of QMS effectiveness and input into Clara’s priorities and objectives.
- Provide effective and timely communication of product quality issues, to ensure mitigation of risk.
- Drive continuous improvement (CI) initiatives to enhance the Quality System and ensure compliance to corporate policies and procedures.
- Promote a culture of Quality first, ensuring continued focus on the developing awareness and positive engagement of all employees towards the continued improvement of Quality.
Have you
- BS degree in Engineering/Science or other relevant field; Prefer Master’s Degree or equivalent additional coursework. [essential]
- 5-8 years’ experience in Quality Engineering in Medical Device or other regulated manufacturing environment (biotech, pharma, military/space). [essential]
- Demonstrable experience in the use of Continuous Improvement activities e.g. Six Sigma techniques. [desirable]
- Certified Quality Auditor; ASQ or ISO 13485. [desirable]
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System
