Johnson & Johnson Loopbaan
Requisition ID: 1805657376W
This position is based in the European Headquarters (EHQ) in Belgium. This position is responsible for maintaining Quality and Compliance at EHQ.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- As Field Action Coordinator:
- Executes Quality Hold, Stop Shipment, Products Recalls and Field Corrective Actions
- Ensures the receipt of the Field corrective action and Stop shipments by all concerned parties and provide reconciliations
- Ensures delivery of the information to all customers identified through the traceability file via the affiliates
- Ensures the reconciliation between the signed customer acknowledgment forms and the traceability files of the Field Corrective Action
- Acts as preliminary contacts for affiliates by responding to questions and providing assistance
- Ensure rework activities at the European Distribution Center, EDO, Courcelles, are done per applicable procedures
- Is responsible for the inspection of the returned products at EDO
- Ensure record retention policy and procedures are implemented. Act as Record Retention Coordinator for the Quality Department
- Training Coordinator for Quality Department and ensure training metrics are green for BWI EMEA
- Investigates and develops solutions to procedure and process related issues
- Participates on project teams to improve processes within the European HQ or at BW global level including QA cage reduction project and country Repack-Relabel activities oversight. May lead project teams.
- Develops in-depth understanding of EP procedures and Biosense Webster devices.
- Alert appropriate individuals when specific events or deviations in data are detected.
- Ensuring personal and company compliance with all National and company regulations, policies and procedures.
- Perform all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo.
- Responsible for communicating any issues or relevant information to the EMEA Quality Project manager Performs other duties assigned as needed
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
- QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- EDUCATION and/or EXPERIENCE: BS/BA degree in business or science with at least 3 years’ experience within a QA environment; or a similar experience within a regulated industry; or equivalent combination of education and experience.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
- English proficiency oral and written. Must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate; including:
- Communication – written & verbal in a clear, concise & effective manner.
- Interpersonal skills – interact with all levels, personalities, cultures & disciplines of organization to produce required results.
- Investigative & analytical – to establish possible options for action.
- Results oriented – in a fast-paced environment.
- Leadership skills.
- Project management – in an environment with multiple tasks & tight timeframes.
- Knowledge of applicable quality, CE mark (Medical Device Directive) & ISO (International Organization for Standardization) requirements
- Customer focus.
- Clinical expertise.
ADDITIONAL POSITION REQUIREMENTS
Occasional travel will be required. This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
EXTERNAL AND INTERNAL INTERACTIONS
The Quality Sr Specialist will interact with all EMEA departments and with J&J EMEA affiliates, BW EMEA field persons, International Technical Services, US complaints team, Clinical Safety department, EMEA Clinical team, Responsible Manufacturers, National Competent Authorities and Regulatory as needed.
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Johnson & Johnson Medical NV (7546)