Duration: 12 Months (with possibility of extension)
Are you a proactive Quality Engineer with a passion for ensuring top-tier compliance? We're seeking a meticulous professional to maintain the QMS and drive validation excellence.
The Opportunity
You will be instrumental in keeping our QMS "Audit Ready," owning CAPAs, and leading internal quality training. This role offers a dynamic blend of QMS oversight, hands-on validation, and critical documentation responsibilities within a regulated environment.
Key Responsibilities
- QMS & Compliance: Maintain an "Audit Ready" QMS, own CAPAs, and conduct internal quality training.
- Data Integrity & Change Control: Drive data integrity and manage change control processes.
- Validation & Commissioning: Create and execute FAT, commissioning, and SAT protocols. Develop, coordinate, and review validation documentation (DQ, IQ, OQ, PQ, MVP).
- Documentation: Perform URS gap analysis, maintain RTMs, and prepare document packs for design gates and package turnover.
- Problem Solving: Proactively anticipate and resolve issues during validation activities.
- Collaboration: Work closely with Operations, Validation, and other teams, ensuring audit-ready documentation.
What You'll Bring
- Education: Bachelor's Degree in Mechanical, Mechatronic/Electromechanical, or equivalent.
- Experience: 2-5 years
- Knowledge: Strong understanding of ISO 13485, ISO9001, FDA 21 CFR Part, and GAMP5.
- Skills: Medical device technical writing and validation/qualification experience for processes, systems, and equipment. Experience in Computerized System Validation (CSV) is an advantage.
- Attributes: Ability to work independently, self-sufficient, proactive, and a strong team player.
