Quality Coordinator

Location Falmouth
Discipline: Industrial & Manufacturing
Job type: Permanent
Salary: £36,000 - £38,000 per annum
Contact name: Danielle Hubbard

Contact email: danielle@smithandreed.co.uk
Job ref: DH 39983
Published: 3 months ago
Startdate: ASAP

​Excellent new opportunity for an experienced Quality Assurance Coordinator, to join and support the Quality Manager within a well-respected business in central Falmouth.

The new QA Coordinator will be required to start immediately on a full time, permanent basis.

Applicants will need to have experience within a similar role, ideally with the medical device industry. Offering plenty of management support, a friendly team environment and the chance to join a renowned business within a niche industry. The successful candidate will need a proven ability to manage multiple projects, excellent communication and strong problem-solving skills alongside a results driven, can-do attitude.

Working hours will be Monday to Thursday, 08:00 - 16:30, Friday 08:00 - 15:30 with some flexibility required to meet business demand.

Applicants might be required to travel around the UK and overseas, project dependant.

Primary Tasks:

•Support in all activities for creation, implementation, and maintenance of Quality Management Systems (QMS) to meet the requirements of ISO 13485, FDA 21 CFR part 820, MDSAP, and relevant Medical Device Directives and Regulations

•Assist in the Corrective and preventive action (CAPA) investigations

•Control of Non-conformities, root cause investigation & follow up actions

•Complaint investigation, monitoring and follow up as required.

•Support in the Planning, Preparation, follow-up, and execution of internal audits

•Support in Preparation for, and hosting of, external audits

•Support SQE with Supplier evaluation, monitoring, auditing and Support in development and implementation of supplier quality program

•Internal training and development as directed

•Control of documents and records

•Support in Change Management, including Engineering Changes (QA Supporting of Engineering (TechOps) projects)

•Assist in the Preparation of Management Review, including monthly statistical trending

•Support in Risk management

•Support in Control of Device History Record, Design History File, Device Master Record

•Inspection & release of finished goods

•Support with any other Quality related investigations and improvements as directed by the Quality Manager

•Escalate immediately to the Quality Manager in any case where potential risks are identified

Secondary Tasks:

•Support in improvement activities related to quality, quantity, and efficiency within all areas of Research Instruments

•Support that SOPs are written, well-documented and maintained, and that all employees are regularity trained on them

•Support to establish KPIs to track and measure performance

•Support that all products are appropriately inspected and tested for conformance to applicable standards, regulations, and customer requirements.

•Supporting Research Instrument quality standards

•Stay updated on quality development in the medical device industry

•Support in Implementation of required tasks for the Annual Management Review Standards

Required qualifications & experience:

•Preferably background in Quality Assurance and Quality Control within the Medical Devices Industry

•Minimum 2 years’ work experience in Quality Assurance

•Preferably knowledge of ISO13485 quality systems

•Preferably knowledge of EU Medical Device Regulations

•Supplier development experience

•Preferably Internal/External audit experience

•Ability to perform Root Cause Analysis

•Proficient in using Microsoft Office Suite Software.

•Effective written and verbal communication skills.

•Proficient interpersonal skills and the ability to work effectively in cross-functional teams.

•Resourcefulness and problem-solving ability

•Results driven work ethic and can-do attitude

•Ability to travel both UK and overseas – if required

Desirable personal skills:

•Proven ability to manage multiple projects and tasks

•Effective written and verbal communication skills.

•Proficient interpersonal skills and the ability to work effectively in a cross-functional team.

•Resourcefulness and problem-solving ability

•Results driven work ethic and can-do attitude

If you think this could be the right opportunity for you, send your CV and apply today!

Email a CV to danielle@smithandreed.co.uk