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Senior Investigator – Quality

In-Office, Környe, Komárom-Esztergom

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Job ID
R-520236
Category
Quality
Location
Környe, Hungary
Region
EMEA

Job Description Summary

Reporting to the Associate Quality Director, the Senior Quality Investigator is responsible for conducting thorough investigations of customer complaints, internal non-conformances, and other quality-related issues within a Medical Device environment.
The role ensures compliance with regulatory standards and internal procedures, aiming to identify root causes and implement corrective and preventive actions (CAPA).
This Quality position collaborates directly with Manufacturing, Engineering, Supply Chain, Quality Platform, R&D, Design assurance, Technical Services, Customer and Suppliers to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks.
Regular, punctual attendance is an essential job function.

Job Description

Job Responsibilities:

  • Engage with the local business and associates toward the effective promotion of organizational goals.
  • Proactively identify and work through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
  • Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by the departmental goals.
  • Development and implementation of best quality practices.
  • Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
  • Maintain positive and cooperative communication and collaboration with all levels of employees.
  • Pursue and maintain a functional knowledge of global regulation affecting the local business.
  • Contributes to the attainment of budget goals by managing department spends, may manage a formal budget.
  • Other duties as required to support the needs of the business.
  • Contributes to the attainment of budget goals
  • Prepare and deliver root cause investigation and technical writing training materials and deliver training to BDM-PS personnel
  • Provide regular updates to the plant leadership team regarding events, deviations and investigations
  • Identify gaps in critical elements of the Quality System or production process and recommend actions

Qualification and skills:

  • Position requires a sound Quality or technical/Engineering background
  • BSc in Quality Assurance or BSc in Engineering or science discipline
  • Professional English (written and oral)
  • Minimum of 5 years of experience in a medical device or regulated industry
  • Proven experience in writing deviations, investigating CAPAs
  • Excellent analytical and problem-solving skills
  • Proficiency in technical writing and documentation
  • Ability to work self-directed at a fast pace dealing with multiple tasks
  • Ability to influence in a matrix organization
  • Analytical - Synthesizes complex or diverse information
  • High positive energy to take on continuous and complex business challenges in a fast-paced environment
  • Persistence to drive to solutions despite obstacles and/or competing priorities
  • Teamwork skills: Ability to work with diverse teams across the organization
  • Judgment and decision-making skills supported by sound technical & business justification
  • Demonstrated ability to discuss both technical and business issues with all levels of management within BD, Customers and Suppliers
  • Statistical knowledge
  • Willing to travel at customer, suppliers or other BD sites upon request
  • Lead root cause investigations, including Situational Analysis (SI) where defective product has escaped BD Control
  • Be a process advisor for investigations
  • Author and review investigation reports
  • Coach and mentor organization and key investigators on proper investigation skills and methodologies

Required Skills

Optional Skills

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Primary Work Location

HUN Kornye - Uveggyar

Additional Locations

Work Shift

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