Oversee all quality assurance functions ensuring compliance with regulatory standards, working closely with production, engineering and third parties to maintain and improve product quality.

 

Key Responsibilities:

• Take full responsibility in maintaining the Quality Management System (QMS) ensuring compliance with ISO 13485.
• Ensure that technical documentation (where appropriate) conforms with audit requirements.
• Manage documentation and reporting for non-conformances (NCR), deviations and complaints.
• Act as first point of contact for all quality issues maintaining the highest level of customer service.
• Oversee and manage CAPA (Corrective and Preventive Action) processes, ensuring timely resolution of quality issues and providing feedback to production/engineering.
• Lead internal and external audits, working with third parties to ensure compliance.
• Serve as the primary contact with regulatory authorities for quality-related matters and during annual auditing.
• Monitor and analyse quality performance metrics, reporting on and providing feedback to Directors/Senior Management.
• Oversee supplier quality assurance, maintaining high standards for sub-contract operations and processes.
• Take responsibility for day to day Health and Safety of the premises, ensuring a safe working environment for all team members.
• Assist with facilities management where required.
• Assist with recruitment, training and induction of new starters when required.
• Perform any other reasonable duties as requested by the Directors of the Company.

 

Experience:

• Minimum 3 years’ experience of Quality Management/Quality Assurance Management in a fast paced manufacturing environment (Essential).
• Knowledge of ISO 13485 (Desirable).
• Experience of working with regulatory bodies.
• Hands-on problem-solving skills with a focus on efficiency and quality.
• Excellent computer literacy (Microsoft package) with experience of Sage 200 an advantage.
• Educated to Degree level or above in a relevant field (Desirable).

 

Working within a busy engineering environment to produce products partially or completely using CNC grinding machines and manual processes.  Setting/operating various machines within the section e.g. Press Brake, Laser Cutters, Laser Markers and Schneeberger CNC grinders as well as and powered tooling to remove burrs, protrusions, etc.

They will be responsible for producing components to layout sheets as provided, making adjustments to tool offsets, potentially program editing with the ability to select, set and change machine tools. They will be working on highly technical products to tight tolerances and strict quality standards.

This is a varied role and a versatile approach is required.

 

Key Responsibilities:

• Operate multi-axis precision grinding machines to produce consumable medical products to meet customers’ specifications and production standards.
• Read, interpret and understand engineering drawings, standards, geometrical tolerances and surface finishes.
• To ensure all components are machined to within the component drawing dimensions and tolerances.
• To ensure all processes are performed in the most efficient manner and within the set cycle times.
• Operate various types of powered grinders/sanders to remove burrs, protrusions, etc. on surfaces to ensure parts meet customers’ specifications and production standards.
• Operate various production machinery to produce consumable medical products e.g. Press Brake, Laser Cutters, Laser Markers.
• Visual quality inspections.
• Liaising with the management and production engineers to maximise the efficient running of the machines.

 

Skills and Experience required:

• Experience using Schneeberger multi-axis precision grinding machines (desirable)
• Experience in programming or ability/willingness to learn.
• Manufacturing experience within a high precision industry
• Experience using precision measuring equipment (essential)
• Comfortable working to deadlines and tolerances.
• Experienced working in a fast paced environment.
• Pride in work.
• Good attention to detail.
• Team player.
• Safe and efficient approach to work.

Able to work to relevant H&S standards.