Quality & Compliance Lead - Cambridge

Sectors:
Medical devices
Locations:
East of England
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Part time / Job share
Salary description:
DOE
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment
Posted:
06/02/2019
Start Date:
ASAP
Job Ref:
Quality role

Inotec AMD is a venture capitalist backed start up in the MedTech space. We have recently been judged the winner of Cambridge Independent’s Entrepreneurial Science and Technology Awards MedTech start up award.

We are looking for an experienced Quality and Compliance Leader who can work on their own initiative with minimal supervision. The role is based in the company’s office at Waterbeach, Cambridge. If you are inspired by the possibilities of MedTech to make a difference to patient lives , come join us.

Working Hours: Permanent, part time, 3 days a week
Reporting to: CFO/COO

Main purpose of the job
This role will oversee the Quality function and play a pivotal role in managing product design and release. You will work closely with both the development, clinical and marketing team to enhance our processes and quality management systems and thereafter ensure compliance to them.

Essential Duties and Responsibilities
• Develop product specifications and release criteria, alongside the Operations Manager
• Oversee product certification and re-certification
• Manage, supervise and maintain excellent technical files, quality systems and processes, coordinating all functions of the business
• Monitor GMP compliance standards, reporting any short fall to management
• Point of contact with MHRA and for any product retrieval activities
• Management of non-conformances including the raising of them, closure of open action and taking remedial action
• Being the conduit for communicating changes internally and externally, and for formal updates to
product registrations
• Manage post-market surveillance and vigilance activities
• Manage Notified Body relationships and interactions with other regulatory/government bodies (e.g. FDA, EMA, NICE, etc.)
• Internal audit responsibility
• Keep abreast of quality and regulatory latest developments

Qualifications & Experience
Qualified Person (QP)
ISO 13485
CE marking for medical devices
Experience in operating in GMP regulated space

IT Skills
• Confident in the use of IT facilities, including Microsoft Office suite and QM
• Strong system skills with the ability to create and run reports

Competencies
• Previous experience of working to deadlines with a strong sense of urgency
• Reliable and self-motivated
• Excellent organisational and time management skills
• The capacity to prioritise tasks and work under pressure
• Analytical and risk-based decision making
• Effective and formal communication
• A professional presence and attitude
• Strong team player with excellent communication skills both written and verbal with good written and spoken English

Closing Date:
13/03/2019

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