Job Information
BD (Becton, Dickinson and Company) Senior Investigator – Quality in Környe, Hungary
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
.
Primary Work Location
HUN Kornye - Uveggyar
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.