Otodynamics Ltd, based in Hatfield Hertfordshire has designed and manufactured electronic medical hearing testing instruments for sale to hospitals/private clinical and military facilities around the world for over 30 years.
As the companies Quality Assurance Officer, you will strengthen and bring added value to the QA Department and be responsible for ensuring that all aspects of the companies QA system is performing to both company and regulatory standards. Helping to drive the quality performance forward, providing training including where required, undertake trend analysis, review and maintain quality documentation including SOPS, works instructions ensuring that they are effective, efficient, relevant, and understood. Ensure detailed and accurate record keeping is maintained throughout the company with high GMP/GDP and that records are easily retrievable whenever requested.
This is an excellent opportunity for someone with a strong passion for QA, looking to join a forward-thinking company with a strong commitment to the development of its people, products and its quality system.
- Ensure that the company continues to operate in accordance with Medical Device standards and regulations including but not limited to, FDA and ISO.
- Preparation, review and updating of QMS documentation.
- Ensuring that internal and external QA documentation is prepared and completed correctly as per the regulations and company SOPs.
- Maintaining systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval.
- Undertaken investigations in conjunction with the Manufacturing Specialist within agreed time frames ensuring all reports detailed and are completed in appropriate time.
- Updating and maintenance of Quality documents e.g. product specifications.
- Assisting with the preparation of the Quality Management Reviews.
- Assisting with the preparation of in-house training and external training.
- Perform QA checks on documentation prior to release of products for sale.
- Assist in managing the artwork control process in line with relevant SOPs.
- Provide administration support to Managers.
- Carrying out of internal audits and ensuring that the review, monitoring, reporting of the inspections are completed. Ensuring audit action items are closed within the agreed time frame and any opportunities for improvement are recorded.
- Assisting with audits and checks on suppliers ensuring the review, monitoring and reporting of the audits.
- Assisting with preparation for Health / Competent Authority and Notified Body inspections and prepare regulatory inspection responses.
- Facilitating inspections by Third Parties
- Act as the point of contact from internal and external contacts/suppliers for general queries relating to Quality Assurance (QA).
- Assist with the negotiating and completing Quality agreements with both suppliers and customers.
- Provide Quality Assurance (QA) support to initiate, engage and escalate critical and major compliance issues through QMS processes, including CAPAs and deviations.
Your Skills & Experience
- 3+ years of experience in the medical device industries. Specific experience working in either a quality systems administration role or quality assurance/engineer role is a requirement for this position.
- Recent user experience of electronic Quality Management Systems. Experience in of Qpulse is Desirable
- Previous experience maintaining a Quality Management System including completing Audits, CAPAs and Deviations.
- Trained auditor ISO13485:2016 or relative experience diserable
- Strong background in the application of ISO13485, FDA and GMP/GDP standards.
- Previous experience in regulatory inspections, supplier audits and customer audits.
- Strong English literacy
- Being able to work with a team or independently
- Able to work under pressure
- Good communicator and influencer
- Honesty, reliable and hard working
Employment Type Permanent
Advertiser Type Agency