Your new company
Is one of the biggest medical device manufacturers of Hungary
Main Accountabilities of the new Quality& Engineering Manager:
- Determine the overall quality and continuous improvement strategy for department to in line with management and corporate overall strategic plan.
- Build strong quality systems for determining the appropriate infrastructure and resources required for department to achieve business objectives.
- Ensure internal processes for highest product quality and competitive advantage.
- Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and the Continuous Improvement initiatives, as they relate to Supplier and Manufacturing Controls.
- Review and Approve Supplier Quality Agreements and the Approved Supplier List
- Oversee investigations of Supplier and Manufacturing quality issues to insure timely closed loop corrective actions and prompt reports.
- Implement, monitor and maintain regulatory requirement with sustainable approach.
- Rollout and control Environmental, Health and Safety compliance and improvement.
- To supports all aspects of Regulatory requirement for Products and Processes in manufacturing and outsources suppliers/partners. Regulatory requirements filed accurately and on time.
- Promptly communicate regulatory developments / news to organisation and relevant suppliers/Partners.
Project Activities and Sustainable Manufacturability
- Create key results for the team build and execute a roadmap of projects that align with the company’s strategic mission. You will continuously apply and evolve agile approaches to fit your team, project, and functional area needs.
- Engage cross-functional teams and customer in the prioritisation and execution of identified manufacturability optimise/lean process improvement opportunities and reduce total cost of ownership.
- Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
- Ensure all Device Master Records (DMR) properly documented including but not limit to Drawing, Works-instruction, Process / Product Qualification, First Article Inspection report, validation report, risk Assessment and Customer Release paper.
- To ensure sustainability of product/process for entire Product Life Cycle.
- Plan and control Product and Process Qualification
- Plan and control Supplier and Customer Qualification
Proper documentation of each change for complete backward and frontward traceability Resource and Building Competence
- Budget, plan, monitor and improve engineering and quality resources.
- Recruit employees; assign, direct, and evaluate their work; and oversee the development and maintenance of staff competence and retention of knowhow within the organization.
- Enthusiastic role model to ensure high engagement cross functional team and to embrace/ embody the quality culture across the organization
- Coach – Work with people on your team to help them to do their best work and grow. You define and foster an identity for the team that includes a reputation for high quality, reliability, and inclusivity. Define the business goals for the team then create and execute on a plan to meet those goals.
- Cultivate and develop critical skills within the team to aid in tackling problems and sustainable manufacturing system including but not limit to LEAN, 5S and Module Production System.
What you'll need to succeed
- Ensure Compliance, Safety and Traceability of each process of manufacturing.
- Successful Audit with close loop action for all improvements and processes optimization.
- Transform Voice of Customer into organization.
- Continuous improvement for customer satisfaction.
- Promptly report including but not limit to KPI, Customer Report, Project Status.
What you need to do now
- University technical or Engineering degree (Bsc, Msc) at least 8 years of experience in Quality / Engineering field (Prefer medical industry)
- At least 5 years in a leadership position
- Knowledge of ISO 13485 and international experience a plus
- Skill level of computer literacy (Windchill and SAP knowledge is an added advantage)
- Strong leadership and communication skills
- High level of ethics, Accountability/ownership and effective conflict management
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.