Job Information
BD (Becton, Dickinson and Company) Quality System Leader in Környe, Hungary
Job Description Summary
The Quality System Leader is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with medical device regulations and standards, with the leadership of the Quality System team. This role involves leading quality assurance initiatives, managing quality documentation, and ensuring that all processes meet the required quality standards.
Job Description
Key Responsibilities:
Quality Management System (QMS) Implementation and Maintenance:
Maintain quality management systems at the plant, based on ISO 13485 and related corporate standards
Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other relevant regulations
Develop and maintain quality processes and documentation
Act as the primary quality representative for regulatory audits and inspections
Ensure accurate and timely reporting of quality metrics and initiatives
Quality Assurance:
Responsible for internal and external quality audits. Prepares and organize external audits. Ensure each key contributor is available and prepared
Oversee process for corrective and preventive actions (CAPA) and ensure the timely and appropriate execution
Ownership at change control process
Training and Coaching:
Train and coach associates on QMS processes and regulatory requirements
Ensure that employees are compliant with quality standards through regular training sessions
Collaboration and Communication:
Work closely with cross-functional teams, including internal (Production, Training/CI team, Engineering) and external (WW Quality System, Regulatory Affairs)
Collaborate with external providers and suppliers to ensure quality standards are me
Report to management on quality issues, trends, and effectiveness
Qualifications:
Education:
- BS/MS in Engineering or a relevant Life Science discipline
Experience:
5+ years of experience in a similar position
10+ years of experience in manufacturing environment within automotive-, electrical- or medical device industry
Experience in quality auditing (hosting and executing)
Skills:
Fluent in Hungarian and English
Expertise in implementing and maintaining Quality Management Systems (QMS)
Strong leadership skills to guide and motivate QS team and other cross-functional teams
Excellent communication skills for effective collaboration and reporting
Strong analytical skills to identify and resolve quality issues
Proficiency in data analysis and quality metrics reporting
Ability to work effectively in a team
GMP and ISO 13485 knowledge is nice to have
Additional Requirements:
Ability to work in a fast-paced and dynamic environment
Ability to manage multiple projects and prioritize tasks effectively
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.