Our Corsham based client are looking for an experienced QA Manager who will be responsible for coordinating the activities required to meet Quality /Medical device and IVD Standards and regulations.
They will also monitor and advise on the performance of the quality management system and will produce data and generate reports on performance, measuring against set indicators.
QA Manager Salary £40,000 to £45,000
Monday to Friday varied working patterns available, discussion held on application.
if you are interested in this position and have the relevant certifications please contact Mitchell on 07 88 59 14 07 6.
Experience and attributes
*ISO9001, 13485 is a must.
*Strong management style.
*MedSap or FDA a plus but not essential.
Role Specific Responsibilities and Duties, directly or through reportees
*Report directly to the Managing Director.
*Promote quality achievement and performance improvement throughout the organisation.
*Mentor the quality assurance team Supervisors, quality control technicians, including the preparation and delivery of staff performance reviews and career development activities.
*Reporting on agreed QA Key Performance indicators (KPIs).
*Maintain awareness of the business context and company profitability, including budgetary control issues
* Maintain the internal auditing programme
* Undertake and report on trend analysis
* Champion a continuous improvement programme, including visual management
* Monitor and progress CAPA liaising with QA Regulatory manager
* Roll out Electronic QA system, Qualsys
*Identify relevant quality-related training needs and delivery of training.
*Liaise with customers, colleagues, auditors to ensure the execution of corrective and preventive actions and compliance with customer specifications.
*Monitor performance gathering data and producing statistical reports.
*Ensure tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated thoroughly.
*On occasion, be called upon to take minutes or Chair management meetings.
*Accept responsibility and make decisions appropriate to the level of the role.
General Responsibilities and Duties
*Take equal responsibility in identifying skill and knowledge development needs and suggesting ways to address these.
*Carry out daily activities in line with the Company’s policies, procedures, and processes, updating appropriate records and performing appropriate transactions.
*Keep senior management informed of any significant changes in any areas related to the role.
In addition to the main duties there will also be other job-related tasks that will need to be actioned by you to support the running of the Company. These duties will form a less significant part of the role.
*Authority to reallocate the budget as you see fit through the year once the overall budget has been signed off.
*You have the authority of to determine the strategic planning process for Quality Assurance, liaising with senior management team.
You need to have or to develop skills and be proficient in the following areas:
*Attention to detail and strong accuracy.
*Remain calm under pressure and meet deadlines.
*Excellent spoken and written communications skills.
*Prioritise workload and work effectively.
*Financial and Budget management
*Relationship building skills, with the ability to collaborate, persuade, and influence
*Provide a professional and friendly service
*Be results and target orientated
*Personal drive and self-motivation
*Apply a positive attitude and approach to all situations, e.g. where a problem or concern arises, this should be brought up alongside a recommended solution which ideally has a win/win outcome for all concerned
*You are expected to develop and use your own plans, strategies, and management tools to achieve your goals. However, management needs to be aware of, and sanction these plans and strategies.
Management’s responsibilities to you
*Supporting your self-discovery of solutions to problems.
*Work with you to further your knowledge and skills needed for you to perform your role to the best of your ability
*Ensuring you have the resources you need to achieve the goals.
*Keeping you informed of the overall context of the parts of the Company you aren’t directly involved in.
*Ensuring your remuneration and benefits are in line with your level of performance and the value you represent to the Company.
We wish all our candidates the very best of luck with their application.