Are you a Senior QA Officer looking for an exciting new opportunity? Do you want to work for a large Medical/Pharmaceutical company that make a real difference in the world? Would you be interested in working in an environment where you are valued and offered progression? Are you looking to work in a state-of-the-art facility? If so this may be the opportunity that you have been searching for…
The responsibilities of the Senior QA Officer will be as follows:
- Establish and maintain quality system to meet all applicable requirements for medical device
- Non-Conformances, CAPA’s, Validation, Audits
- Batch release
- Work with procurement on supplier quality standards, supplier quality agreements, metrics
- Premarket QA / Design Assurance / R&D Quality
- Utilize knowledge and experience to identify, solve and document problems and risks within the quality system.
- Serve as a resource and mentor to colleagues with less experience, including QA Officers.
- Work closely with QRA management in developing quality objectives.
- Establish and maintain strong relationships with internal and external stakeholders.
- Maintain working knowledge of relevant regulations and quality system requirements that affect the business.
What you will need to do the job:
- Graduate degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
- Experience in the IVD field preferred experience very beneficial
- Experience conducting and hosting quality system audits.
- Extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 and ISO 13485. Strong working knowledge of medical device design controls would be an advantage
- Experience in medical device Design Controls and Risk Management
The successful Senior QA Officer will be offered the opportunity to join an Organisation that are having an extremely successful period in the industry and you will drive improvement across the facility. Therefore, if you are a Regulatory Affairs professional that is looking for a dynamic, fast-paced environment, who would thrive in an organisation that has a genuine appetite for continuous improvement please get in touch.