Manager/Quality Manager

2 weeks ago

Yarnton Oxfordshire, United Kingdom Alloyed Full time

Meshworks’ Quality Manager (Alloyed’s Orthopaedic Business)

At Meshworks we are revolutionising orthopaedic treatment by increasing accessibility of personalised orthopaedic implants. Our Operations and Quality function is pivotal for business growth.

Alloyed is seeking a Quality Manager with a keen eye for detail to join the team. As the Quality Manager, you will play a crucial role in maintaining and improving the quality management systems within our company. You will be responsible for ensuring adherence to ISO13485 standards throughout our manufacturing processes, promoting a culture of quality excellence and continuous improvement. Your primary objective will be to guarantee the delivery of high-quality products that meet or exceed customer expectations while driving operational efficiency. Training will be provided where required.

At Meshworks, we design and additively manufacture personalised orthopaedic implants and instruments ( We are developing innovative software technologies in design, materials and additive manufacturing.

Alloyed is a young venture-funded company of about 130 world-class metallurgists, mechanical engineers, and software developers working across multiple global offices in the UK, Japan, United States to build the future of advanced metal components. To do this it uses proprietary software packages which combine advanced machine learning and physical modelling to invent better alloys, devise better ways to process them, and design better 3D-printed components.

Oversee Quality Management Systems (QMS):
Ensure compliance with all relevant quality standards, regulations, and customer requirements.
Collaborate with cross-functional teams to establish and revise quality policies, procedures, and objectives.

Quality Assurance and Control:
· Establish quality control plans and procedures to monitor all stages of the design and manufacturing process.
· Develop and implement inspection and testing protocols to verify product conformity and compliance.
· Implement statistical process control techniques to monitor process performance and drive continuous improvement.

Supplier Quality Management:
Collaborate with the procurement and design teams to evaluate and qualify suppliers based on their quality capabilities.
Conduct supplier audits and assessments to ensure adherence to quality standards and raise SCARs when applicable.
Establish and maintain strong relationships with suppliers to foster a collaborative quality-focused environment.

Training and Development:
Provide training and guidance to employees on quality management principles and practices.
Develop and deliver educational programs to enhance quality awareness and competency.
Foster a culture of quality and continuous improvement by promoting employee engagement and involvement.

Performance Measurement and Reporting:
Define and track key performance indicators (KPIs) to measure the effectiveness of the QMS in conjunction with the work completed so far by the Quality Director in the US.
Prepare quality reports and present findings to senior management, identifying areas of improvement and recommending action plans.
Participate in management reviews to evaluate the overall performance of the QMS and provide recommendations for enhancement.

5+ years’ experience in Quality Management ISO13485.
~ Accreditation to BSI level Internal/Lead Auditor training (or equivalent).
~ Solid analytical and problem-solving skills, with the ability to interpret and analyse measurement data effectively.
~ Experience working in a precision medical device environment.
~ Experience in Risk management as applied to Medical Devices
~ Proficient with Microsoft Office (Excel, PowerPoint, Outlook, Word).
~ Experience working with quality management software.
Experience in Quality Management for a legal manufacturer of medical devices
Familiarity working with regulatory bodies on device approvals.
Any applications without a supporting statement may not be considered.

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