
Chief Quality Assurance Officer
12 hours ago
Quality Engineer Role
This is an exciting opportunity to join a team as a Quality Engineer. In this position, you will be responsible for providing quality engineering support to various teams within the organization.
Main Responsibilities:
- Review and understand validation documentation, change requests, design and process FMEA's, test summaries, software validation, microbiological assessments, and critical system work orders.
- Provide quality engineering support to the research and development and sustaining engineering departments up to and including transfer to production, understanding design assurance activities, reviewing associated documents, and ensuring compliance with regulatory requirements.
- Liaise with production and quality control by providing quality engineering support to incoming quality control, in-process, and final quality control.
- Support internal audit, supplier audit, and regulatory audit programs conducting, documenting, and reviewing complaint investigations.
- Risk assessment of customer complaints, non-conformances, and CAPAs.
Qualifications and Skills:
- A third-level qualification in science, engineering, or a relevant technical discipline.
- Proven knowledge and experience of working with ISO 13485, ISO 14971, the medical device directive, EU medical device regulation 2017/745, and the FDA QSR, including 21 CFR part 820 and 21 CFR part 11.
- Proven knowledge and experience of all aspects of validation, including design, process validation, and software validation.
- Good working knowledge of statistics.
- Strong interpersonal skills with the ability to communicate effectively at all organizational levels.
Benefits:
- The opportunity to work in a dynamic team environment.
- The chance to contribute to the development of new products and processes.
- Professional growth and development opportunities.
We Offer:
- A competitive salary and benefits package.
- The opportunity to work on challenging projects.
- A collaborative and supportive work environment.
Contact Information:
Please note that we do not provide contact information for job applicants. We recommend checking our website regularly for updates on available positions.
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