QMS Specialist

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Quality Management System (QMS) Specialist is responsible for Quality Management Systems (QMS) implementation and maintenance, in the areas of CAPA management, Documentation/Records management and Trainings. He/She shall interface with the relevant departments/ functions at the respective system houses in Quality System harmonization/alignment and projects.

Your Responsibilities

Ensure the compliance of QMS towards applicable medical devices regulations and standards, in area of QMS processes such as Audits, CAPA, Change Control Management, Documentation/Records Management and Training.
Assist in planning and execution of both internal audits and external audits. Including the management of audit findings.
Provide training and hypercare to users on Document and Change control Management system and Learning management system.
Create, update and develop the training material for QMS.
Support QMS team members in sustaining the training administration by learning system
Reviewing with respective process owners on what specific training is required for staff certification and development.
Provide timely reporting on the QMS KPI and training status
Assist in on management review meeting preparation.
If assigned, will serves as the organizational focal point for Change Review and Control Management
If assigned, Administration and Management of the CAPA Process for the site using electronic system or manually.
Coordination and presentation of CAPA status on site and with the system house as well.
Maintain the Quality documentation through the use of electronic documentation system such as PLM, SAP and MES.
Develop and administer electronically the work instructions (FPV) and other documentations used in production using the MES system.
Assist in overseeing the process of Quality Records archival (eg. DHR), retrieval and its maintenance.
Ensure prompt distribution/retrieval of controlled documents to/from users/functions.
Assist in conducting quality processes, quality awareness training, including new hire orientation.
Assist on QMS improvement initiatives as required.
Support, execute projects and any others quality related activities as directed by supervisor.

Your Profile

Technical / scientific degree at college / university level
At least three years’ work experience in a quality function in regulated environment (medical devices/pharmaceutical industry)
Good communication and interpersonal skills
Proficient in Microsoft Office especially in Words and Excel
Independent worker as well as in a good team player
Knowledge of CGMP regulations and concepts preferred, particularly good documentation practices
Experience in document control, change control, CAPA or other quality system preferred
Attention to detail required
Good time management and organization skills
Microsoft Outlook, Word, Excel, Powerpoint, Sharepoints, Teams
Aras PLM, SAP ,Manufacturing Execution Systems (MES), Learning Management System (LMS) will be an advantage
SAP and Success Factor User experience is a plus
Familiarity with medical device manufacturing process is a plus.
Knowledge on basic problem-solving tools such as Ishikawa, 5 Why, 8D and etc.
Prior experience in using electronic document control system is a plus.

What we offer

being encouraged to think and act entrepreneurially
working in global teams and projects
developing yourself professionally

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Singapore| Working hours: Full-time

Apply now under:

Job ID: 57885 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.