Client: Biotechnology company
Project Details:
- 9-Month contract
- 40 hours per week
- On-site, 5-days per week
Responsibilities:
- Ensure compliance with applicable quality standards (eg, FDA, ISO 13485, ICH Q10) across all operations.
- Support product development and manufacturing through risk management, validation, and design control activities.
- Lead root cause investigations and implement effective CAPAs.
- Drive continuous improvement initiatives within the Quality Management System (QMS).
- Collaborate cross-functionally to support audits, inspections, and regulatory submissions.
Candidate Requirements:
- Bachelor's degree in engineering, life sciences, or related field.
- 7+ years of quality engineering experience in the biotechnology, pharmaceutical, or medical device industry.
- Proven experience with CAPA, validation, risk management, and audits.