Quality Engineer

2 weeks ago

Singapore BIOTRONIK APM II PTE. LTD. Full time $60,000 - $120,000 per year
The Quality Management System (QMS) Engineer is responsible for Quality Management Systems (QMS) implementation and maintenance, in the areas of Change control management, Documentation/Records management and Trainings.

He/She shall interface with the relevant departments/ functions at the respective system houses in Change control management and Quality System harmonization/alignment.

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.
  • Collaborate with the Global Business Process Organization (QMS) in Berlin with regards to the deployment and sustaining of the global harmonized process.
  • Assist in planning and execution of both internal audits and external audits.
  • Shall perform the review of technical documentations such as validations, DHR, DMR during audit to ensure compliance.
  • Responsible to review the analysis and action done to address the audit findings through the ACS process. (Include review of action taken on production processes, documentations and changes that affects the product.)
  • 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
  • Serve as the organizational focal point for Change Review and Change control Management in close collaboration with all stakeholders. Ensure that all QMS and Design/Process changes are properly executed, reviewed, implemented with full documentation.
  • Administer the Change Management and Document Control using Electronic System or manual convention.
  • Responsible as the Change coordinator/Analyst for site, in collaboration with the change review board from system houses
  • Review of technical changes affecting the process, design and functionality of components and products and advise the appropriate documentations required.
  • Review of impacted technical documents such as VPP, VER, PSP, TSP and etc affected by the change.
  • Providing advice on the validations or verifications required to qualify the technical changes submitted.
  • Responsible for driving improvement in Change Control management and documentation/Records system, including rolling out of new change/documentation system, optimization of cross site technical change review platforms, and record archival management
  • Assist in on management review meeting preparation.
  • Track progress and status of change request, and maintain relevant reporting
  • 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.
  • Review of monitoring data results (Yield, Reject rates, NC) that will be used to decide if CAPA is required.
  • Providing guidance on the CAPA process including the performance of the Root Cause Analysis using the different problem solving tools.
  • Member of the CAPA Team that reviews all the identified actions and effectiveness target for all the CAPAs raised.
  • Maintain the Quality documentation through the use of the documentation 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

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