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: www.biotronik.com/careers
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.
