The Ability Matters Group (AMG) is a leading provider of prosthetics, orthotics, wheelchair services & products, serving the needs of more than 75,000 patients at 30 centres across the UK and Ireland.
Ortho Europe is the manufacturing arm of the Ability Matters Group. Ortho Europe, established in 1990, is a major European manufacturer and distributor of prosthetic and orthotic product. Headquartered in the UK, Ortho Europe also has offices in France and Netherlands and distributors across Europe and the rest of the World.
The role will involve the evaluation, maintenance and improvement of technical file documentation to meet quality & regulatory requirements.
The role holder will implement and improve manufacturing procedures to ensure that they are efficient, effective and compliant with quality and regulatory requirements
Key Responsibilities & Tasks:
- Maintain & improve technical file documentation containing or referencing documents generated to demonstrate conformity to applicable quality & regulatory requirements including, but not limited to:
o general description of the medical device, intended use/purpose, and labelling, including any instructions for use;
o Design and manufacturing information
o General safety and performance requirements
o Benefit-risk analysis and risk management
o Product verification and validation
- Support the development of robust manufacturing processes to ensure that final products are safe, and meet customer expectations, while keeping the manufacturing process as effective and cost-efficient as possible.
- Implement processes / procedures ensuring that their effectiveness is verified and their performance is measured / monitored.
- Train colleagues in new procedures ensuring that records of training are created and maintained
- Supporting departmental continuous improvement
Skills & Personal Attributes
The position requires the job holder to possess:
- Experience in Lean manufacturing techniques with the ability to apply them into practical situations
- Practical application of Observe, Plan, Do, Check, Act cycle (OPDCA)
- Organized 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.
Ideally, the job holder will also possess:
- Project management skills
- General knowledge of medical device regulatory affairs framework
- Full, clean driving licence
- Degree Level or equivalent working level accreditation
To apply please email your CV with a covering letter ASAP to firstname.lastname@example.org
Location: Riverside Park Road, Middlesbrough, TS2 1UU
Submitted: 14th April 2021
Salary: Competitive with excellent benefits package