Quality Assurance Specialist

Quality Assurance Specialist
Salary: 38,000 - 40,000
Sheffield

Adept Resourcing have been retained by a manufacturing facility in Sheffield. Our client specialises in the creation and supply of premium orthopaedic products, embodying the highest standards of quality and precision.

The Role:
To effectively maintain and keep up to date the Quality Management System (QMS) through formal document control and provide the necessary information as a manufacturer of medical devices. This role reports to the Quality Manager.

Responsibilities:

• Maintain and update the QMS through effective and authorized document control.
• Manage the company's Qpulse and QMS management systems.
• Support the management of complaints and vigilance, including notifying competent authorities and notified bodies such as MHRA and BSI.
• Coordinate the Internal Audits & Supplier Audits Programme, ensuring internal audits are carried out effectively within the specified timescales.
• Update and distribute Visual Standards for production, quality, environment, and health & safety.
• Coordinate and produce management review presentations on agenda items as defined by the Managing Director.
• Coordinate external ISO13485 audits (e.g., BSI audits) and corrective actions in collaboration with the Quality Assurance Manager.
• Manage and maintain the library of national and internal standards.

Person Specification

• Degree qualified or with 5 years' experience in a relevant field.
• Highly computer literate in all Microsoft Office packages and a confident user of QA software packages such as Qpulse.
• Ability to work independently and as part of a team.
• Proven track record of working effectively with and as part of cross-functional teams.
• Awareness of medical device regulation, legislation, and ISO standards, and their application to company compliance requirements.
• Capable of consistently producing high-quality work, on time and to specification.
• Willing and able to prioritize demands to meet company goals and objectives.
• Excellent communication skills with the ability to interact with and influence colleagues at all levels of the company.

Benefits:

• 25 Days annual Leave Plus 8 Bank Holidays
• Onsite parking
• Training & Development opportunities
• Summer & Christmas events
• Early Finish on a Friday 12:30pm