Company Requirements:

We are seeking a highly motivated and well organised Quality Manager to become an integral part of our team. Working for a long established (since 1977), highly regarded, Surgical Instrument Manufacturer in Sheffield, the successful candidate will lead all Quality Management functions relating to the manufacture of our Hand Made Surgical Instruments.

Working closely with the Company Director, Business Development Manager, Production Foremen and Shop Floor Staff, the successful candidate will maintain our existing ISO 13485:2016 system, and further develop and improve processes in line with our business needs. They will lead our transition from MDD to MDR in advance of the 2024 deadline. Experience in the medical device sector is advantageous.

Job Role:

As Quality Manager you will be responsible for planning, organising, leading and controlling all Quality Management and Regulatory activities. You will ensure that systems and controls are in place to maintain the safety of our medical devices and ensure compliance to all QMS Requirements.

• Understand the needs of the QMS and maintain effective, quality assured processes
• Ensure manufacturing activities are implemented to ISO13485:2016 standards
• Ensure QMS, technical files, and certifications are maintained (including CE marking)
• Maintain existing annual data for our US Agent / Official Correspondent for FDA Registration
• Understand customer needs to maintain effective quality assured processes
• Manage updates and ongoing improvements of the QMS to existing and new standards
• Manage all customer feedback including complaints and ensure these are dealt with in a timely manner
• Make suggestions to identify opportunities for continual improvement and develop new efficient and effective procedures
• Provide guidance and feedback to staff on all levels to drive change and improvement in performance and quality
• Be the representative for notified body audits
• Perform internal audits as per auditing schedule
• Deal with CAPA & NCR
• Coordinate the calibration of inspection equipment

Personal Specification Requirements

The ideal candidate should have experience in a Quality Management Role, preferably within the Medical Device Field.

• Proven experience as a Quality Manager, preferably in medical devices
• Auditor qualification for ISO13485:2016
• An excellent working knowledge of ISO13485:2016
• In depth understanding of Quality Management Systems and standards
• Excellent organisational skills
• Excellent written and verbal communication
• Strong attention to detail
• Ability to prioritise and work to deadlines
• Good interpersonal skills
• Ability to communicate with all levels within the business, and be able to work both as an individual and a strong team player.
• Punctual
• Reliable

Hours:

34.5 hours per week (Monday - Friday)

Permanent Position     

Salary:

Dependent on Experience

Holiday Entitlement:

23-27 days (incremental) + Statutory Days                          

Additional Benefits:

Company Pension Scheme

Company Health Scheme

Please send applications and CV to info@plattsnisbett.com

www.plattsnisbett.com