QA Specialist (1-year Contract)
Key areas of responsibility
- Support post-market surveillance (PMS) activities, including complaint handling, product field actions, adverse event reporting, UDI reporting, and other activities in accordance with applicable local regulatory requirements.
- Support Quality Management System (QMS) activities to ensure compliance with internal procedures and applicable regulatory requirements.
- Support the maintenance and control of QMS documentation, including procedures, work instructions, forms, and quality records.
- Support communications and document preparation for regulatory authorities and Notified Bodies, as applicable.
- Assist with QMS improvement initiatives and process updates under the guidance of the QA team.
- Assist with cross-functional QA projects and support QMS-related systems and documentation.
- Perform other QA administrative and operational tasks as assigned.
Education / work experience
- BS in a science, engineering, business or related discipline.
- 0+ years experience in manufacturing environment or equivalent.
Knowledge / competencies
- Good command of written and spoken English.
- Strong documentation skills with attention to detail.
- Basic understanding of Quality Management System (QMS) and applicable regulatory requirements.
- Proficiency in Microsoft Office applications (Excel, Word, and PowerPoint) and data management.
- Strong communication and interpersonal skills with the ability to work effectively in a cross-functional environment.
- Good organizational and problem-solving skills with the ability to manage multiple tasks.