Quality Assurance Coordinator

CooperSurgical, Inc.; Falmouth; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading medical device company in Falmouth seeks a Quality Coordinator to support the Quality Department. You will manage quality documentation, coordinate training, and ensure adherence to quality standards. Ideal for candidates with a degree and experience in quality assurance. The position offers full-time employment in a collaborative office environment.

Qualifications

• Strong focus on accuracy and thoroughness.
• Ability to identify issues and implement solutions.
• Familiarity with quality standards like ISO 13485.

Responsibilities

• Manage and maintain quality documents and system procedures.
• Gather and report on KPIs to measure quality performance.
• Support preparation for and hosting of external audits.

Skills

Attention to detail

Root cause analysis

Written communication

Verbal communication

Data analysis

Time management

Collaboration

Education

Degree level qualification or equivalent

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

CooperSurgical, a leading fertility and women’s healthcare company, is dedicated to putting time on the side of women, babies, and families during critical healthcare moments. As a division of CooperCompanies, we enable patients to experience life’s beautiful moments through a wide range of products from contraception to fertility, birth, and genomic testing solutions.

Scope

The Quality Coordinator supports the Quality Department at Research Instruments in Falmouth, UK, working closely with the Quality Manager to maintain overall site compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements.

Job Summary

Key responsibilities include managing quality documentation, coordinating employee training and accurate training records, ensuring adherence to regulations and standards, gathering quality data for KPI monitoring, and collaborating with various departments to resolve quality issues and improve processes.

Responsibilities

• Manage and maintain quality documents, records, and quality system procedures to ensure compliance and traceability.
• Gather and report on KPIs to measure Quality Management System performance.
• Effectively monitor and communicate quality management system performance metrics, reporting monthly trending and supporting Management Review.
• Identify Quality Management System‑related non‑conformances and identify trends that require escalation.
• Maintain the Training Matrix and support the Quality Manager with updates of supplier status and Quality Agreements.
• Assist with internal audits and maintain evidence of follow‑up actions.
• Support preparation for and hosting of external audits.
• Assist with Corrective and Preventive Action (CAPA) root cause investigations and maintain evidence of follow‑up actions.
• Support any other quality‑related investigations and improvements as directed by the Quality Manager.
• Take proactive part in the QA team and ensure good cross‑communication between QA members and other departments to meet business demands.
• Collaborate closely with cross‑functional RI teams to resolve quality issues quickly and avoid disruptions.

Travel

Travel to sister sites and suppliers may be required, less than 10% of the time.

Qualifications – Knowledge, Skills and Abilities

• Strong focus on accuracy and thoroughness.
• Ability to identify issues, conduct root cause analysis, and implement solutions.
• Strong written and verbal communication skills to interact with various internal and external stakeholders.
• Ability to work collaboratively as part of a quality team and with other departments.
• Familiarity with conducting data analysis and reporting statistics.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 and MDSAP is desirable.
• Excellent organizational, time‑management and communication skills to handle multiple priorities effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is essential.
• Expertise in MS Office and Adobe Acrobat is desirable, including creating locked, fillable forms in both Word and Adobe.

Work Environment

• Office environment in a shared workspace.
• Moving about the site and on the shop floor where care is needed.
• Nature of work may include long periods of intense concentration, frequent interruptions, multiple tasks and meeting deadlines.

Experience

• Previous relevant experience in a Quality Assurance or Quality Control role in a regulated industry, medical device preferred.
• Experience in ISO 13485 quality systems is preferred.
• Experience in writing technical documents such as policies, procedures, assessments, and reports.
• Experience with document control and GMP.

Education

• Degree level qualification or equivalent.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing