Manager Quality

TERUMO BCT, INC; Vlaams-Brabant; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Terumo BCT, INC. seeks a Quality Manager in Leuven to own and improve the QMS, ensuring CAPA, Document Control, Change Control and Validation processes are effective and compliant.

You will lead a quality team, interface with regulatory authorities, drive continuous improvement, and uphold our policy on quality requirements across manufacturing and service activities. Travel may be required.

Qualifications

• Engineering degree or equivalent to perform essential functions.
• Minimum 5 years relevant experience.
• Minimum 2 years supervisory experience.
• Understanding of electromechanical systems or systems engineering.
• Preferred 5 years in Quality Assurance or Regulatory Affairs for medical devices.
• Preferred ISO 13485 training.

Responsabilités

• Ensure implementation and effectiveness of global QMS processes for CAPA, Document Control, Change Control and Validation at Leuven site.
• Assist in improving quality processes and awareness of associates.
• Release to market all finished products manufactured at Leuven and ensure incoming goods release.
• QMS ownership and responsibility, including audits, training and management reviews.
• Interface with regulatory authorities and participate in audits and inspections.

Connaissances

Regulatory knowledge

Quality Systems

Leadership

Communication

Process ownership

Formation

Engineering degree

ISO 13485 training

Outils

PC software

Description du poste

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 - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
• Knowledge of international medical device regulations and standards (MDD/MDR, ISO 13485, CFR 820).
• Strong product technical knowledge, GMP, and Quality Processes.
• Stronginteractive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, quality specialists, and management.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Must be detail oriented, well organized and able to work independently and in teams.
• Demonstrated ability to lead people and get results through others.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.

Job Segment:

Medical Device, Document Control, Systems Engineer, CAPA, Quality Assurance, Healthcare, Administrative, Engineering, Management, Technology