Manager Quality

JOB SUMMARY

The Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS area(s) of responsibility. Support and improve various Quality System processes to maintain regulatory compliance.

ESSENTIAL DUTIES

• Ensure implementation and effectiveness of the global QMS processes for Nonconformities and CAPA management, Document Control, Change Control and Validation at the Leuven site.
• Assist in improving quality processes and awareness of associates.
• Ensure timely release of incoming materials to production and release of manufactured products to market
• QMS areas of ownership, management, and responsibility may include (as assigned): CAPA, Audit (internal, external, supplier), Post Market Surveillance (recalls / field actions, product risk review, post-market data review), Quality System Training, Document Control, Management Review, etc.
• Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective.
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes: generation and approval of annual schedules, execution to schedule, approval of plans, reports and QMS documents, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
• Monitors the health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
• Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Review, organizing, maintaining and approving procedures, and service manuals. Inform and/or train about quality requirements, control procedures and GMP. Relaying and sending out Service Information for the TE business.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

OTHER DUTIES AND RESPONSIBILITIES

• Quality control of Servicing, Production and Logistics.
• Perform quality inspection/tests and review production records issued by production.
• Release to the market all finished products manufactured by the Leuven site and the incoming goods for production.
• Follow-up on non-conformities detected during incoming inspection, production and servicing.
• Coordinating the communication of quality complaints to suppliers and ensuring timely follow-up on investigations, responses, and corrective actions.
• Support handling of customer complaints related to products manufactured in Leuven.
• Make available declarations/ certificates requested by customers.
• Complete customers surveys and tender questionnaires related to products manufactured in Leuven.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Engineering degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum 5 years relevant experience.
• Minimum 2 years supervisory experience.
• Understanding of electromechanical systems, machine design or systems engineering
• Preferred minimum 5 years experience in Quality Assurance and or Regulatory Affairs, involving medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls.
• Preferred training in ISO 13485.

Skills

• In line with Terumo BCT Core Competencies:
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Emp