Quality & Engineering Manager

Medical device, ISO 13485, Diagnostics

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.
Regulatory Affair
  • 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.
Change Management
  • 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.
Customer Satisfaction
  • 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'll need to succeed

  • 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


What you need to do now
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Summary

Job type
Permanent
Industry
Engineering
Location
Budapest
Specialism
Life Sciences
Ref:
1158117

Talk to a consultant

Talk to Viski Nora, the specialist consultant managing this position, located in Budapest
Budapest, Szabadság tér 7, Bank Center

Telephone: 0036704895290

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