Quality Assurance Manager
- Medical Devices
- Vast (1,0 fte)
- Zuidwest Nederland
- Medical Devices Distribution Center
As Quality Assurance Manager you will provide QA leadership and vision as part of the Global Quality Leadership Team. You will strive for a dynamic 'Culture of Quality' to continuously improve products, processes and Quality Management System (QMS). You will support both the Roosendaal facility and European Distribution Activities to achieve business objectives. Help to fulfil the mission and vision of this company and become the QA leader!
- As the Quality Assurance Manager you will directly oversee the activity of the QA department and staff.
- QA oversight for distribution activities at 3PLs/4PLs across Europe.
- Generate and maintain a plan for the professional development and coaching of all direct reports including annual goal setting.
- Manage direct resources and the operations of quality inspection.
- Develop and maintain an overall strategy for areas of responsibility ensuring communication to key stakeholders.
- Responsibility for developing, implementing, and maintaining the QMS
- Ensuring audit readiness and compliance is maintained in line with required standards, regulations and company procedures.
- Support and lead on the sites operational excellence program ensuring the quality function work towards efficient and effective processes.
- Responsibility for preparation and management of the QA operating budget in conjunction with the Facility Manager.
- Provide QA technical direction and guidance to achieve objectives.
- Represent as the site Management Representative / Person Responsible for Regulatory Compliance if required.
- Decision making authority with respect to product quality.
Quality oversight for:
- finished goods product release where applicable.
change control, complaints, internal audit, risk management, notified body/health authority external audits.
- the introduction of changes to existing products and of new innovative products.
As the Quality Assurance Manager you have:
- 8-12 years of experience in the Quality field.
- 5+ years experience in a Medical Device/Pharma Industry in a Quality Leadership role.
- Bachelor Degree in Quality/Science/Engineering/ Logistics or a related discipline.
- Thorough Knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR etc.).
- Knowledge of internal & external audit management with proven experience.
- Good working knowledge of continuous improvement and root cause problem solving.
- Good working knowledge of Good Distribution Practices for medical devices
- Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
- Able to communicate in English (both written and verbal)
- Dutch language skills are a plus
- Good interpersonal skills with the ability to work as part of a cross-functional team.
- Excellent analytical skills.
- Have a continuous improvement mindset and demonstrated change management skills.
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