Quality System Management Officer, Uk

**Quality System Management Officer, UK**

**_Highly Competitive Salary + Excellent Benefits + Career Enhancement_**
- Location: Huntingdon, UK_

As an experienced Quality System Management Officer, based in our Huntingdon office, you will establish and maintain quality management systems for regulation compliance and facilitate the business of Mindray UK. Acting as an interface with HQ Quality Centre, you will align the quality management requirement from HQ with Mindray UK, communicate and cooperate with a wide variety of process owners in the UK to improve our quality management systems.

**What you’ll be doing**:

- Overall responsibility for maintenance of Mindray UK’s Integrated Management System for ISO9001 and ISO14001 to assure its continuous compliance, suitability, adequacy, and effectiveness
- Monitor and action any changes to medical device regulations, update and implement any such changes that are applicable to Mindray UK
- Overall responsibility for maintenance of the IMS manual, policies, and procedures, etc
- Work with the various department heads to ensure a regular review of department specific processes and procedures are carried out. Make updates where required to match true business practice, whilst ensuring the requirements of the ISO standards are maintained
- Responsible for management review, including management review planning, meeting material preparation, meeting arrangement as well as meeting resolution follow-up
- Responsible for internal audit and outsourcing supplier audit, including audit planning, audit implementation, and following up the audit findings and getting the relative process owners to address the corrective action against the root causes until closed
- Responsible for external audit to assure relevant quality license or certificate effective to support product registration or business
- Responsible for continuous quality system improvement and align the quality management requirement from HQ to local
- Day-to-day management and update of the online IMS Toolbox in conjunction with consultant for IMS documents and records control
- Day-to-day responsibility for the UK ISO task schedule, including the management / updating of the schedule where required
- Monitoring and measuring of Mindray UK’s energy/CO2e usage (Building and company funded cars), including carbon offsetting calculations
- Ensure all registers (corrective action, controls, legal, risk & opportunities, FGAS etc) are up to date
- Responsible for quality related training, including training planning and training organization
- Work closely with customer service and sales for customer complaints, especially incidents and serious incidents
- Participate in QMS management of other EU subsidiaries of Mindray
- Assist in the establishment of ISO27001
- Any other task or activity from time to time in relation to QMS, IMS

**Who we’re looking for?**
- Bachelor’s degree or equivalent in law, medicine, pharmacy, engineering or another relevant scientific discipline
- Strong proven work experience in managing Quality Management Systems, preferably in medical device industry
- Good Knowledge of Quality
- ISO9001 and ISO14001 auditor certified or trained is preferred
- A strong communicator with excellent written and oral communication skills,
- Fluent English as the working language
- Experience in building consensus and able to impact outcomes without always having line management authority
- Experience at working both independently and in a team-oriented, collaborative environment
- Able to conform to shifting priorities, demands and timelines
- Willing to travel in EU and Mindray HQ
- **You will require the right to work in UK without company sponsorship**

**What’s in it for you?**

This is an excellent position if you’re looking for a role with difference and one in which you can
**really shape our success**. Our European business is a highly successful part of our innovative challenger organisation with
**real opportunities to disrupt the market**, under strong leadership from our Senior Leadership - this is the time to join for the journey, helping drive the success and
**shape of great things to come** This role is the start of a planned growth within this area, therefore
**opportunities for career development will be vast**.

**A bit about us**

Mindray Europe, as part of the global Mindray business, offers a wide selection of bespoke benefits dependent on your location, along with a competitive compensation package and a commitment to a long-term working relationship. With industry leading training and development available to you, you are sure to have a highly rewarding and mutually beneficial, career with Mindray, in a culture that values honesty and fun
- Our goal is to continuously improve and sustain an inclusive culture in which diversity provides deeper customer insights and creates a competitive advantage in the markets we serve. By attracting, developing, and engaging the b