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Quality Manager- Clara. Reporting to the Operations Director, and with a dotted line to Nelipak’s 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 Clara Site Leadership Team to achieve the site’s key performance metrics and deliver its strategic objectives.
Job Responsibility
Manage and develop the Clara Quality team against agreed targets and budgets according to company standards, policies and procedures
Develop and implement Quality Management strategy and plans
Develop, sustain and continuously improve the Nelipak Claras QMS in accordance with Company procedures and regulatory requirements
Identify and manage the Quality Budget
Act as site Management Representative responsible for the planning and execution of Management Review activities
Responsible for the timely processing and closure of customer feedback through the QMS Complaint process
Drive robust timely and effective corrective and preventive action programs through the CAPA system
Develop and maintain internal audit program, lead and support third party audit
Ensure compliance to Change control requirements
Identify, develop, and report QMS trending, metrics and KPIs
Provide effective and timely communication of product quality issues
Drive continuous improvement (CI) initiatives to enhance the Clara Quality System
Promote a culture of Quality first
Requirements
BS degree in Engineering/Science or other relevant field
Prefer Master's Degree or equivalent additional coursework
5-8 years experience in Quality Engineering in Medical Device or other regulated manufacturing environment (biotech, pharma, military/space)
Demonstrable experience in the use of Continuous Improvement activities e.g. Six Sigma techniques
Certified Quality Auditor
ASQ or ISO 13485
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
Nice to have
Demonstrable experience in the use of Continuous Improvement activities e.g. Six Sigma techniques