Quality Systems Specialist

hace 22 horas

Heredia, Costa Rica Bayer A tiempo completo

When you show proactivity and ambition, we'll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose.
Where do you want to go?
What do you want to do?
How do you want to make a difference?
The choice is yours, and we'll help you get there.
Be better together.
Be Bayer.
YOUR TASKS AND RESPONSIBILITIES

Collect, summarize, analyze and communicate quality metrics that will be used as objective evidence for area performance or monitoring quality system health.
Participate in developing and presenting departmental materials for Management Review.
Review and monitor correction, corrective & preventative actions (CAPA), and effectiveness actions; conduct follow-up activities on action items in a collaborative and efficient manner.
Support critical Quality System processes which may include training, corrective action and preventive action (CAPA) activities, calibration, document control, quality audits, change management, validation, etc.
Support the wider QA team in routine activities.
Support the internal and external audit programs.
Provide support in the performance of audits or audit related activities.
Support activities may include actively and directly interacting with inspectors and auditors, acquiring required information, summarizing data in reports, following up on actions, and actively participating in the planning process.
Maintenance of auditable quality records and files.
Communication with internal and external customers to distribute, reconcile, and verify quality records.
Responsible for completing documentation in a timely manner and in accordance with business standards.
**Complaints**: Responsible for overseeing the analysis of complaints received from customers, including the revision of history of the device and its trends.
Ensure complaints are processed within the established timeframes.
Oversee the correct execution of cases by Gatekeeper and RQU.
Responsible for reporting complaints to management level and corporate (Pharmacovigilance).
Responsible of the monitoring and trending of customer complaints.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Comply with all requirements, duties and obligations under the Quality Management System.
Comply with the implementation of standards and occupational health programs established by the company, through compliance with those recommendations to perform the work safely and also advise the company on improvements to prevent incidents or illnesses, that could actually damage the integrity of workers and/or the facilities and assets of the company.
Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products and other assets directly related to their area of work, in order to avoid incidents that affect the productivity and distribution of our products, which could cause an economic impact for the company or a breach with our customers, suppliers, shareholders and/or other key audiences.
Other duties and projects may be assigned to the employee once the corresponding training is completed.
WHO YOU ARE

Advanced University studies (at least 75%) in Engineering, Production, Quality or similar (mandatory).
Bachelor degree is desired.
At least 2 years of experience in the manufacture of Medical devices (required), and 1 year mínimum of experience in the support of technical operations, development, testing, manufacturing or quality areas preferably in a regulated environment.
Upper Intermediate English level in reading, writing and speaking (required).
Ability to understand, interpret, and communicate general instructions in English, such as drawings, quality manuals, SOPs, work instructions, forms (and QAFs).
Ability to make decisions and present different points of view in another language, for example management reports and data summaries.
Experience reviewing and monitoring required corrective and preventive actions (CAPA); conduct follow-up activities on required action items.
Proficient in Microsoft Office (Word, Excel & PowerPoint).
Experience in maintaining quality records and documents is required.
Strong organizational skills, including ability to follow to drive actions to completion across multiple teams.
The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
Must be able to work as part of a team, meet deadlines and take instruction from multiple persons.
Proactive and self-motivated, able to multi-task and work under pressure in a fast paced environment, and to self direct as required.
Adaptable and able to face changes in a positive way.
Versatility, flexibility, and a willingness to work within evolving priorities.
Critical thinking and capable of solving probl

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