Quality Manager
Boston Scientific
- Kerkrade, Limburg
- Vast
- Voltijds
Is viewed as a leader in the areas of QSR, cGMP, ISO and MDR standards/regulations within the Quality Organization, making appropriate decisions using the Quality Manager / QA Director as the final arbitrator on critical quality decisions. Leads a team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization. Responsible for implementing continuous improvements and provide vision and leadership for strategic projects and maintaining the Quality System, including Quality Assurance mandates. Identifies and assures optimal product and process quality within quality system and regulatory requirements.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Location: Onsite KerkradeYour responsibilities include:
- Pro-actively demonstrate leadership in the implementation of all Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
- Foster a diverse workplace that enables all participants to contribute and develop to their full potential in pursuit of organizational objectives.Provide management and direction to employees and aid in their development.
- Exercise a high degree of technical autonomy through developing and managing an efficient and effective Quality Management System which complies with all current medical devices standards and regulations.
- Active participation in the local business management team to solicit input and consensus support for quality decisions, compliance with all procedures and standards, as well as implementing continuous improvements initiatives and compliance programs.
- Provides vision and leadership for strategic projects with significant impact within the site, region or globally.
- Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.
- Participates in the internal audit program and plays a lead role in the preparation and execution of audits by external parties.
- Responsible for NCEP & CAPA management and Supplier Management activities.
- Responsible for sustaining Third Party Logistics (3PL) activities from a Quality perspective and work on process improvements in collaboration with the 3PL stakeholders.
- Collaborates and liaises with the Global Quality Systems Stewards and relevant working groups to drive continuous improvement.
- May direct and control the activities of the Quality budget as it applies to their site/region.
- 7+ years' MedTech experience with Bachelor's Degree or equivalent and 3-5 years of supervisory experience.
- Comprehensive understanding of the EU MDR, ISO standards and cGMP
- Demonstrated experience in team management and development
- Experience in SAP ECC/S4 HANA, project management, problem solving and risk management techniques.
- Effective leader, fully motivated to achieve and demonstrate best practices in line with the department & global objectives.
- Good social and communication skills
- Strong analytical skills, eager to improve and results oriented.
- Advanced knowledge of the English language (verbal and written)
- Experience with supply chain distribution and packaging
- Experience with 3rd Party logistics
- Medical device industry experience