Quality Systems Officer

Quality Systems Officer

Job Title: Quality Systems Officer
Contract Type: Permanent
Location: Cambridge
Salary: Competitive
Start Date: ASAP
Reference: 16263 AP
Contact Name: Adrienn Prezenszki
Contact Email:
Job Published: June 13, 2019 09:50

Job Description

Are you experienced within the medical device industry? Do you have full knowledge of ISO 13485:2016? Are you an individual aspiring to lead and dedicated to seeing tasks through to completion? If so, this permanent position is an excellent opportunity to build your career in an Operational Quality position with an award-winning medical device company in Cambridge.

The Role
You will be responsible for working alongside the Quality Lead developing and establishing the Quality Management System. Working closely with the Development, Clinical, Operations and Marketing team based within the UK and abroad to manage and maintain an excellent quality management system, processes and GMP compliance standards. You will oversee the management of non – conformances and raising them as well as overseeing root cause analysis. Managing post-market surveillance and vigilance activities will be part of your duties as well as developing product specifications and release criteria alongside the Operations Manager. As a pivotal member of a small team you will need to have excellent organizational and communication skills and be confident in your abilities and problem - solving rationale. Excellent communication and influencing skills will help you to manage relationships and interactions with regulatory bodies e.g.: FDA, EMA, NICE etc.  You will need to be up to date with the latest quality and regulatory developments and ideally have experience with conducting internal audits.

The Company
An award winning and exciting start-up company and a globally recognized innovator with a focus on providing wound care technology to make a difference in patient’s lives. Their culture is acquired from a passion for medicine, understanding patient’s needs, respect among employees and commitment to internal and external customers. They continue to build their presence within the US as well, so it is an exciting time to join the company.

Due to the fast-paced nature and size of the company, my client is looking for someone with in excess of 3 years relevant Quality Management experience gained within a medical device organization. Full understanding of ISO 13485:2016/MDD/MDR is essential and experience from a GMP regulated setting will be advantageous. You will have strong IT system skills and the ability to create and run reports employed in the management and reporting of quality data on a regular basis. You would ideally have knowledge of MDSAP and Internal Auditor training. You need to be self-motivated, confident and someone who can make this role their own and operate with a certain degree of autonomy. You will have a collaborative approach and the ability to influence and work alongside others.

The role offers a competitive salary, 23 days holiday, pension plan and company bonus scheme.