Ortho Europe is a leading manufacturer and distributor of prosthetic, orthotic and seating products. Our goal is to promote independence and quality of life by providing robust, innovative and effective devices to thousands of people who need mobility support. We aim to deliver a first class service for users whilst applying the most advanced and exciting technical solutions available to patients.
The role holder will have overall responsibility for Quality at Bradford, the largest OE Manufacturing site in the Ability Matters Group. They will conduct internal audits, oversee the local CAPA management system, and support the drive for continued Quality and Regulatory compliance. They will be responsible for a Manufacturing site that is certified to ISO 13485 standard, with some requirement to work across other Group sites.
Key Responsibilities & Tasks:
Acts as Management Representative, with responsibility and authority that includes:
Ensuring that the processes needed for the Quality Management System (QMS) are documented;
Reporting to Top Management on the effectiveness of the QMS and any need for improvement;
Ensuring the promotion of awareness of applicable Regulatory requirements and QMS requirements throughout the organisation
Support the operations team in the development and implementation of robust manufacturing processes helping to ensure that final products are safe, and meet customer expectations, while keeping the manufacturing process as effective and cost-efficient as possible
Plan, perform and report internal audits in accordance with ISO13485 and company procedures at Bradford and (occasionally) Abingdon sites
Administration and management of site QMS CAPAs (Track, monitor, advise, review/validate, approve, and perform VoE checks)
Lead QMS CAPA meetings with relevant stakeholders
Train relevant stakeholders in Root Cause and Corrective Action methods and techniques.
Ensure application, monitoring and reporting of Group QMS (as site level)
Prepare data for management review meetings
Hold local, interim QMS reviews to assess its suitability, adequacy and effectiveness (pre-management review)
Plan, perform and report supplier audits
Manage key supplier CAPA program
Working with various stakeholders in the manufacturing process such as design teams, suppliers, manufacturing teams, and customers.
Drive continuous improvement and compliance of the QMS
Help prepare and run internal training sessions to ISO13485
Support the Management Representative in their core responsibilities including data analysis and Certification Body / customer audit hosting)
Assist in the creation, review and approval of controlled documents
Assist in preparation of monthly Quality Report and associated dashboard
Support creation and monitoring of Group Quality Objectives
Support continual improvement projects as required by Line Manager
Skills & Personal Attributes
The position requires the job holder to possess:
Minimum of 2 years’ recent, practical experience of Quality Management systems, ideally ISO13485
Competent and trained internal auditor (Ideally certified internal auditor / lead auditor to ISO13485)
Practical application of Observe, Plan, Do, Check, Act cycle (OPDCA)
Organised and methodical
Calm and patient
Positive and proactive ’can-do’ attitude.
Ability to build and maintain excellent working relationships internally and externally.
Excellent interpersonal and communication skills.
Exceptional attention to detail.
Attitude of continuous improvement.
Experience of and comfortable working in a fast paced, flexible organisation
Diplomatic but also assertive as required.
Able to prioritise, plan and organise efficiently and work with multiple conflicting priorities.
Collaborative and collegiate style, achieving results through coaching and support.
Self-motivated and uses initiative.
Highly literate & numerate.
Good working knowledge of IT systems.
Confidential and professional.
Flexible working style.
Full DBS clearance.
Ideally, the job holder will also possess:
Project management skills
Working/practical knowledge of MDD (93/42/EEC)
Working/practical knowledge of MDR (2017/745)
General knowledge of medical device regulatory affairs framework
Full, clean driving licence
Recognised Quality-related qualification e.g. Chartered Quality Institute (CQI) – desirable but not essential.