Job Description

Responsibilities

• Supports the Global QMS team in ensuring the conformity of QMS to established applicable standards and regulations
• Supports QMS Engineer in verification of effectiveness of QMS by conducting internal audits and participating in external audits
• Maintains all documents in Document management system.
• Creates and coordinates training plans in Training management system, ensuring Training Timeliness, including weekly reporting
• Leads and coordinates projects to harmonize and improve existing QMS documents
• Acts as the administrator for Document Management System (DMS) and Training Management System (TMS); responsible for employee on-boarding and off-boarding account changes, and assist to resolve minor technical issues in close collaboration with the IT support team.
• Ensures archival records are easily retrieved and properly maintained, identified and traceable, by updating and maintaining master list/log sheet of quality records, coordination and maintenance of Quality Records archival and retrieval from Document Management Centre.
• Maintains document control room in a neat and tidy manner.
• Assist in maintaining and coordinating of engineering changes and its supporting documentation.
• Support Engineer in CAPA coordination and related activities
• Working closely with colleagues across other departments to ensure that requested documentations are properly prepared and submitted to the requestor.
• Adhere to company EHS requirements, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others.
• Represent RAQA Department in ad-hoc committees and cross functional projects.

Requirements

• Diploma or Degree in relevant engineering or Science field.
• Minimum 2 years of relevant experience, preferably in a medical device company with knowledge of Good Manufacturing Practice.

• Language proficiency in English.
• Knowledge of ISO13485/ USFDA QSR/cGMP (21 CFR Part 820)/ MDSAP is preferred

Personal Trait Profile

• Positive working attitude, willing to learn, meticulous and able to multi-task.
• Team player and able to work with cross functional teams.
• Quality and safety focused.

Key Relationships

Internal

• Production
• R&D
• Global sourcing
• Engineering
• RAQA
• Purchasing
• Logistics

External

• Auditors
• Suppliers

When you join us, you\xe2\x80\x99ll also be joining Danaher\xe2\x80\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\xe2\x80\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you\xe2\x80\x99ve ever wondered what\xe2\x80\x99s within you, there\xe2\x80\x99s no better time to find out.

Danaher