ERBA Molecular is an innovative molecular diagnostics company applying its commercially validated proprietary technology in sample preparation, amplification and detection to produce novel workflow based solutions to reduce the complexity of molecular testing.
We are currently recruiting for a Quality Manager to join our team in Ely on a full-time basis. The QA Manager will be responsible for documenting and maintaining a Quality Management System and maintaining its effectiveness in accordance with the requirements of relevant international standard(s) on behalf of the company and its affiliates as well as providing regulatory input into the Product Development process and CE marking submissions.
- Achieve and maintain ISO13485 certification for the organisation.
- Support the Product Development Group and provide input in the Product Development Process where required from a Quality and Regulatory perspective and in the creation of technical files.
- Maintain the quality management system. Manage the day to day aspect of document control and issuance of training records related to QA, manage the training matrix reflecting and identify gaps in training per operator role. Work with team leaders to advise on required training and deliver training on quality SOPs.
- Conduct spot checks and internal quality audits regularly and in a supportive constructive manner, coordinate a review of the results and ensure corrective actions are agreed and implemented in the timescales set.
- Support members of the Operations group from a Quality aspect, including supplier management, product transfer and lab management.
- Lead the business in problem resolution and root cause analysis methodology in order to identify corrective and preventive actions and minimise the risk of (re)occurrence. Support operators in investigations and provide guidance where required on non-conformances and planned deviations.
- Drive quality and business improvement opportunities to deliver customer fulfilment, reduced waste and higher profitability.
- Support the development of LEAN methodology while driving improvements across the business.
- Measure operators’ engagement with the Quality System on a regular basis and obtain feedback on areas to improve, while remaining compliant at all times. Design and carry out own activities to promote Quality within the organisation.
- Develop effective relationships with other external and internal partners; including but not limited to the company’s Product Development Process and Group, manufacturing partners; licensees; and other members of the ERBA Group to ensure quality and regulatory compliance for the business, ensuring ownership of quality as an ongoing and proactive activity.
- Promote a positive health and safety culture in the workplace by following the training received and complying with all health and safety procedures.
- Act as deputy to the QA and Operations Director in Quality matters.
The successful candidate will have:
- Degree level education or equivalent experience with either a Scientific, Quality or Engineering background is desirable
- Quality management experience:
- Quality experience within the IVD industry
- At least 3 years’ experience within an ISO 13485 environment
- Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical file
- Experience in product development and creating design history files
- Experience of promoting Continuous Improvement
- Experience in presenting effectively at team/company meetings and, when appropriate, outside audiences
- Ability to work independently and be a self-starter
- Experience of CE Marking Submission applications for US and Asian markets
- Experience of FDA, MHRA, MDD, new IVDR directive
- Ability to suggest improvements/solutions to practical problems or procedures
- Microsoft Sharepoint 2010 knowledge
Please submit your CV and covering letter to d.washtell@erbamannheim quoting reference QA-BV.
Closing date for applications is Thursday 9th November 2017.
Thank you for taking an interest in the career opportunities at ERBA Molecular; we are a successful and dynamic company that is always looking to add the right candidate to our team.
Direct applicants only – no agencies please.
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