Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £40000 - £45000
Job Status: Permanent / Full Time
Job Title: Quality Engineer
Salary: £40-45k per annum
Working hours: 8:30am to 4:30pm (may allow for some working from home on occassion)
Working with a Medical Device manufacturer you will be starting in the company as a Quality Engineer with a view to be trained alongside their QA/RA Consultant and MD to become the sole person to drive quality within the business, with this will come promotions to Quality Manager/Director. All training courses will be provided to add qualifications as you grow with the company. As an overview we are looking for someone with 3-5 years experience as a Quality Engineer in the Medical Device field, that has experience with auditing, forthcoming and has a real drive to make a difference in the company.
- Drive all elements of quality assurance support to manufacture a range of medical devices; including product development, manufacturing operations, information systems, and quality systems activities.
- Ensure external and internal quality system requirements are adhered to throughout product and process lifecycles.
- Develop and implement software design plans, detailed design specifications, design verification/validation plans, test protocols/reports, traceability matrices and risk assessments.
- Additional emphasis will be placed on Software Validation activities.
- Perform risk assessments and validation assessments for product and process software changes.
- Lead the software risk management process throughout the entire product lifecycle.
- Lead a team through investigations and corrective actions for software related CAPAs.
- Maintain a working knowledge of applicable regulatory standards and requirements.
- Maintain and continually improve Software Quality System procedures representing best practices and GMP, ensuring that the procedures meet all applicable regulatory standards and requirements.
- Develop development and training protocols and deliver to employees on principles of software validation, software risk management, and general software quality tools.
Education & Experience:
- B.S. degree in Computer Science, Engineering, Biology, Chemistry or related discipline.
- 5+ years’ experience in Quality Engineering, information systems, computer science or management preferably in a regulated industry.
- One year in a leadership role for product software validation and software quality assurance activities. (desirable not mandatory)
- Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDA’s “General Principles of Software Validation and “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices , 21CFR Part820, 21CFR Part 11, EN ISO 13485, IEC 60601, EN ISO 14971:2012, IEC 62304). Emphasis will be placed on experience with the CE technical files.
- Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs.
- Working knowledge of product software, analytical process software, manufacturing process software, and quality system software validation methods and requirement
- All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions.
If you feel you have what we are looking for, please click apply now to submit your CV. If you would like to know more information please get in contact with Harvey in the Life Sciences team.