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Senior Product Validator
2 weeks ago
The role of a Quality Assurance Specialist is crucial in maintaining the company's Quality Management Systems and working on moderately complex quality-related projects.
Key Responsibilities:
- Apply broad knowledge of Quality principles to complete moderately complex assignments.
- Utilize problem-solving skills to deal creatively with complex situations and make informed decisions in day-to-day operations.
- Identify problems and possible solutions, taking appropriate action to resolve them.
- Develop skill in data analysis techniques and resolve missing/incomplete information.
- Drive business improvements through continuous improvement initiatives.
- Act as escalation point for quality-related non-conformances and CAPAs.
- Ensure compliance cross-functionally in alignment with regional objectives for collaboration and multi-site certification.
Requirements:
- Third-level qualification.
- Minimum 5 years of experience in the medical device industry with at least 3 years of progressively responsible positions.
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ISO13485/ISO14971/GMP).
- Awareness of relevant laws and regulations (e.g. CE/FDA/PAL).
- Broad knowledge of engineering and technical applications applied in the development of medical devices.
- Excellent interpersonal, written, and verbal communication skills.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets.
