Quality & Regulatory Manager

We are currently recruiting for a Quality & Regulatory Manager to join our team in Ely on a full-time basis.  The QA/RA 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.

Key Responsibilities:

  • Achieve and maintain ISO13485 certification for the organisation.
  • Maintain a quality management system which includes:
  •  documented statements of a quality policy and objectives;
  •  a quality manual;
  •  documented procedures and records required by international standard ISO 13485;
  •  documents needed by the organisation to ensure effective planning, operation and control of its processes;
  •  any other documentation specified by national or regional regulations;
  •  a robust and compliant CAPA, complaint, NCR, internal audit process; and
  •  supplier management processes.
  • Identify the processes needed for the quality management system, their interactions, and their application throughout the organisation.
  • Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
  • Ensure the availability of information necessary to support the operation and monitoring of these processes.
  • 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.
  • Support the development of LEAN methodology while driving improvements across the business.
  • Build effective relationships with all Erba Molecular staff, creating a culture of Quality by Design and open communication between the Quality department and other departments.
  • 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.
  • 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.
  • Support other members of the Operations group from a Quality aspect, including supplier management, product transfer and lab management.
  • 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.
  • Drive quality and business improvement opportunities to deliver customer fulfilment, reduced waste and higher profitability.
  • Act as deputy to the QA and Operations Director in Quality and Regulatory matters
  • Promote a positive health and safety culture in the workplace by following the training received and complying with all health and safety procedures.

The successful candidate will have:

  • Quality experience within the medical device/pharmaceutical 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 of promoting Continuous Improvement
  • Lead Auditor training
  • A degree level education or equivalent experience with either a Scientific, Management, Quality or Engineering background is desirable
  • Experience of CE Marking Submission applications for US and Asian markets desirable
  • Experience of FDA, MHRA, MDD desirable
  • Knowledge of new MDR directive desirable
  • Experience in presenting effectively at team/company meetings and, when appropriate, outside audiences
  • Confidence in training others and ensures own expertise is disseminated as widely as necessary
  • Ability to communicate at all levels and bring a culture of employee engagement to the QMS through own positive supportive communications to employees
  • Ability to suggest improvements/solutions to practical problems or procedures
  • Responds to the needs of team members and provides help in areas of own expertise
  • Ability to work independently and be a self-starter
  • Microsoft Sharepoint 2010 knowledge desirable

Please send a CV and a covering letter to This email address is being protected from spambots. You need JavaScript enabled to view it. quoting reference QA-WEB.

Closing date for applications is Friday 11th August 2017.

Direct applicants only – no agencies please.

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.

 

Recruitment – Data Privacy Notice:

Your personal information will be held securely in Erba Molecular’s systems so that we can look after your potential employment relationship with the company.  

Personal information may include, but is not limited to, your application; curriculum vitae; emails; letters; evidence of entitlement to work in the UK; references; and any additional information provided by you or others in support of your application.

We will not retain your personal information for longer than is necessary for processing your application, or for legal or regulatory requirements.