about 2 months ago
This is an opportunity to join a world class international business working in the area of medical devices.
Type of position: Contract 18 months
Rate £50-55/ hr + paid holidays “paye” inside IR35
Location: North West/ North Wales
Industry: Pharmaceutical / Medical
Date posted: 10/05/2022
To ensures all manufacture of products and any supporting activities comply with the client’s and relevant regulatory standards.
To support manufacturing and project delivery and ensure a high-quality standard is maintained.
To instil a strong quality culture across all GxP activities.
- Supports inspections by regulation bodies, including BSi.
- Proficient in EDMS, SAP, Trackwise and spreadsheet / database software.
- Supports the Internal Audit processes
- Actively supports and influences technology transfer teams in the translation of product Design Requirements into Manufacturing Requirements; including the Quality Control Plan and ensures that these are included in the Design and Development Plans and addressed timely in Design Reviews. Assures work is complete, meets standards and requirements appropriate for the type of product.
- Supports the introduction of new GxP equipment into production, providing guidance and enforcing high quality standards throughout the respective project.
- Supports the implementation of continuous improvement activities by assessing impact on the Quality system and providing guidance on appropriate activities required for implementation.
- Investigates process and product performance issues and leads or participates in multifunctional evaluation of products in the market. Evaluates data using statistical tools. Lead or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Lead or actively support Product Change Control.
- Supports manufacturing, providing guidance to ensure high quality standards are maintained.
- In support of the quality system, provide effective leadership, training, and guidance.
- Provides leadership as subject expert in Risk management and Control plan activities. Maintains risk management procedures, ensuring alignment with relevant regulatory standards.
Skills and experience
- A Bachelor’s Degree in an engineering or scientific discipline is desirable.
- Proficient with software such as Word, Excel, Powerpoint, and Project, as well as statistical tools (e.g. Minitab).
- ISO 9001 or ISO 13485 Lead auditor certification is desirable.
- Demonstrated experience in Pharma/Medtech industry
- Knowledge and experience of working with a Quality Management System within Medical Device manufacturing
- At least 2 years’ experience in a quality engineering or a similar role in a medical device ,life sciences technology or pharmaceutical company. Demonstrated application of change control processes in a complex and regulated manufacturing environment.
- Experience with all phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialisation.
- Regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211.