Quality Manager

Proclinical is currently seeking a Medical Device/Component Project manager role to support an exciting project within a Sterile Packaging Facility at our clients Macclesfield site.

The successful applicant will be responsible for the introduction of new/modified Medical Devices/Packaging Components. They must lead and co-ordinate key suppliers and internal stakeholders including Contracts Management, Purchasing, QA, Device Manager, Device Technical Manager, Process Lead, Operators to ensure the solution is fit for purpose.
The role requires strong technical skills alongside project management, problem solving, and a good understanding of Aseptic Packaging requirements.
This is a temporary role with an immediate start date, with an end date expected to be Q3/Q4 2019.

Job Responsibilties:

• Lead and co-ordinate activities between key suppliers.
• Lead and co-ordinate key internal stakeholders including Contracts Management, Purchasing, QA, Device Manager, Device Technical Manager, Process Lead, Operators to ensure the solution is fit for purpose and represents value for money.
• Ensure device quality and manufacturability are built into the development process to ensure good process robustness from launch.
• Understand and optimise performance of manufacturing operations through effective control of device specifications / variability relating to manufacturing process.
• Chair Monthly Commercial Meetings
• Update, present and track progress of key activities on the PDR Board, escalate concerns and seek resolution
• Work closely with the Device Manager and Sterilisation Support Officer to assure sterilisation of the agreed presentation format through Experimental Programme and Validation Programme
• Work closely with the Device Manger to support Change control Impact Assessments and closure of actions within the agreed timeframes.
• Ensure a supply of Devices/Components in line with Project schedule for de-bugging, commissioning, FAT and SAT
• Ensure alignment and buy in from Contracts Management, Operations, Warehousing and the Irradiation Suppliers
• Ensure risk assessment/management is fully built into the development and product maintenance processes.
• Develop technical solutions to a diverse range of problems using structured problem-solving tools and sound analytical and conceptual thinking.

Skills and Requirements:

• Demonstrable knowledge and manufacturing experience of the overall drug and device development and commercialization process from development, launch and through life cycle management.
• Experience of working with devices as a device design engineer, device quality engineer or device manager working in operations and/or development.
• Experience of developing Medical devices/Components for use in Aseptic processes.
• Educated to BSc level with experience in an appropriate discipline and have professional credibility within the business and industry.
• Understanding in the disciplines of Packaging and Device development, analytical, formulation and physical Science and global supply chain to identify appropriate solutions for management of devices and deliver value to the organization.
• Thorough understanding of principles, applications and management of SHE, cGMP and Device standards and legislation (for example, FDA CFR 820 and EU MDD 93/42/EEC).
• Evidence of excellent communication skills and building excellent relationships with customers and device component suppliers.
• Project management and problem-solving skills with a thorough understanding of design work and design control procedures, such as risk analysis and design reviews associated with device legislation.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.