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About the role
Key responsibilities & impact- Organize, support, and document training performance across the company
- Monitor and track progress and status throughout the training process
- Initiate improvements to the training process
- Follow up and ensure compliance with company policies
- Plan and manage internal and external audits
- Select auditing personnel and schedule audits
- Review audit content
- Follow up on the timeliness and completion of action items and corrective action plans
- Assess quality gaps and initiate improvements in quality processes
- Apply investigation methodologies
- Create new procedures as applicable
- Support QMS processes including change control, quality plans, NCc/CAPAs, CSV/tooling validation, and customer complaints
- Report to the QMS Team Leader
Requirements
What you’ll need- BSc in Biomedical Engineering, Engineering, Life Science, or equivalent
- 1–3 years of experience in a pharmaceutical or medical device company
- Experience in quality assurance, preferably with QMS management/projects (advantage)
- Knowledge of quality management principles, standards, and regulations, including FDA CFR 820, ISO 13485, and ISO 9001 (advantage)
- Proficiency in Microsoft Office programs
- Good English, written and verbal
- Ability to collaborate effectively and embrace diverse perspectives
- Customer-focused approach to meeting internal and external customer needs
- Innovation and enthusiasm in creating new opportunities
- Accountability and ownership of challenges while upholding standards
- Ability to motivate and develop talent and achieve goals
Benefits
Comp & perks- Hybrid work arrangement: 4 days a week from the office and 1 day from home