Quality Manager

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. You will work closely with engineers and technicians, ensuring that all work is carried out according to process specification., Oversee Quality Management Systems (QMS):

• Develop, implement, and maintain the company's ISO13485 compliant QMS.


• Ensure compliance with all relevant quality standards, regulations, and customer requirements.


• Conduct internal audits to assess the effectiveness of the QMS and identify areas for improvement.


• 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.


• Run the Material Review Board periodically, classify non-conformances and interface with engineering teams.


• 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.


• Drive continuous improvement efforts with suppliers, addressing non-conformances and implementing corrective actions.


• 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 in having successfully passed re-certification audits for ISO13485.


• Experience working in a precision medical device environment.


• Experience in Risk management as applied to Medical Devices


• Organised and able to work independently, but also to collaborate with a diverse, fast-moving team.


• Proficient with Microsoft Office (Excel, PowerPoint, Outlook, Word).


• Hands-on attitude and willingness to learn new skills.


• High level of attention to detail.


Desirable

• Experience with metal additive manufacturing.


• 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.


• Understanding and Experience of using ISO 14971:2019 and 62366:2016
  
  Meshworks is a subsidiary business of Alloyed Limited. At Meshworks, we design and additively manufacture personalised orthopaedic implants and instruments (www.meshworksimplants.com). 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.


• Casual dress


• Company events


• Company pension


• Cycle to work scheme


• Employee discount


• Employee mentoring programme


• Employee stock ownership plan


• Enhanced maternity leave


• Enhanced paternity leave


• Free parking


• Life insurance


• On-site parking


• Private dental insurance


• Private medical insurance


• Referral programme


Schedule:

• Day shift


• Monday to Friday


Work authorisation:

• United Kingdom (required)