At a Glance
- Tasks: Support quality assurance in manufacturing medical devices and improve processes.
- Company: Established precision engineering manufacturer with a focus on quality-critical components.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Dynamic role with direct access to the Quality Manager and excellent career development.
- Why this job: Make a real impact in a close-knit team while ensuring product quality and compliance.
- Qualifications: Experience in quality assurance within regulated environments and strong Excel skills.
We are recruiting a Quality Engineer for an established precision engineering manufacturer producing high-value, quality-critical components for medical devices, aerospace, defence and other regulated sectors. This is a newly created role within a close-knit manufacturing business, offering direct access to the Quality Manager and genuine scope to improve processes, influence standards and introduce better ways of working. The company is also part of a growing group of specialist engineering and medical-technology businesses.
The role will primarily support the site's Quality Assurance & Regulatory Affairs (QARA) function, with a strong focus on maintaining compliance, supporting the Quality Management System (QMS), managing external audits and working with external certification and regulatory bodies. Alongside this, you will provide hands-on quality support across the manufacturing operation.
Your role
You will support quality and compliance across the full manufacturing process, from incoming materials and supplier documentation through to production, inspection and batch release. Working closely with the Quality Manager and wider QARA function, you will help maintain and improve the site's QMS, support regulatory and compliance activities, and ensure the business remains prepared for external audits and certification requirements. You will also work closely with Production, Engineering, Inspection, suppliers and customers to identify quality issues, implement corrective actions and drive continuous improvement.
Key responsibilities will include:
- Supporting the Quality Assurance & Regulatory Affairs (QARA) function across the site
- Supporting the maintenance, development and continuous improvement of the Quality Management System (QMS)
- Supporting regulatory and compliance activities within a regulated manufacturing environment
- Supporting and coordinating external audits, including preparation, hosting and follow-up of corrective actions
- Supporting the management and ongoing relationship with external certification, regulatory and other relevant bodies
- Supporting internal, customer, supplier and third-party audits
- Investigating internal and customer non-conformances
- Leading root-cause analysis and CAPA activities
- Supporting goods-inwards inspection and supplier-quality improvements
- Making practical disposition decisions on non-conforming products
- Reviewing drawings, specifications, inspection records and CMM reports
- Completing batch-release and traceability activities
- Maintaining and improving procedures, work instructions and controlled quality records
- Analysing KPIs and quality trends to identify improvement opportunities
- Working closely with production, engineering and inspection teams to reduce defects and improve right-first-time performance
- Supporting the ongoing development of quality processes, standards and best practice across the site
What you will bring:
- A Quality Assurance and/or Regulatory Affairs background within a regulated manufacturing environment
- Strong understanding of Quality Management Systems (QMS) and quality compliance
- Experience supporting external audits, certification bodies and/or regulatory bodies
- Strong Excel skills, including creating formulas and using data to produce reports
- Experience with CAPA, non-conformance management and root-cause analysis
- Experience with batch release, product disposition and traceability
- Ability to read engineering drawings and specifications
- Knowledge of manufacturing inspection methods and standard metrology equipment
- Experience with internal audits
- Experience writing and maintaining controlled quality documentation
- Confident communication skills, with the ability to work effectively with production teams, suppliers, customers and external bodies
Experience of CNC machining, AS9100, ISO 9001, ERP or MRP systems, Power BI, Lean, Six Sigma or GMP would be advantageous but is not essential.
Mon–Thu 7:00 am–3:30 pm | Fri 7:00 am–2:30 pm
Quality Engineer - Medical Devices & Precision Manufacturing - Rotherham employer: Vested Talent
Join a dynamic and supportive team at our Rotherham facility, where as a Quality Engineer, you will play a pivotal role in enhancing quality standards within a close-knit manufacturing environment. We offer a collaborative work culture that prioritises employee growth, with direct access to leadership and opportunities to influence key processes in the medical devices sector. Enjoy a competitive benefits package and the chance to be part of a growing group of specialist engineering businesses dedicated to innovation and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer - Medical Devices & Precision Manufacturing - Rotherham
✨Join Local Manufacturing Groups
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✨Apply Directly Through Company Websites
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We think you need these skills to ace Quality Engineer - Medical Devices & Precision Manufacturing - Rotherham
Some tips for your application 🫡
Showcase Your Technical Skills:In the manufacturing-production sector, it's crucial to highlight your technical skills and experience. Make sure your CV features any relevant qualifications, such as certifications in machinery operation or production management, and don’t forget about any specific systems or software you’re familiar with. This can really set you apart!
Emphasise Teamwork and Communication:Working in manufacturing often means being part of a larger team. Highlight your experience in collaborative projects or environments where communication was key. Maybe you have experience with lean manufacturing principles? Talk about how you worked with your team to improve productivity and maintain quality.
Tailor Your Cover Letter to the Company:Don’t just recycle an old cover letter! Take the time to tailor your cover letter to Vested Talent specifically. Mention what excites you about their production processes or products, and how your previous experiences can contribute to their goals. We want to see your enthusiasm for the role!
Use Concrete Examples of Your Achievements:When detailing your work experience, include measurable achievements that can demonstrate your impact. Whether it’s improving efficiency by a certain percentage or successfully leading a project, these specifics can make a huge difference. Numbers speak volumes in the manufacturing world!
How to prepare for a job interview at Vested Talent
✨Know Your Manufacturing Processes
Before you walk into the interview with Vested Talent, brush up on the specific manufacturing processes relevant to the role. Understanding lean manufacturing principles or quality control techniques could give you a solid edge to discuss how you’d fit into their operations.
✨Technical Questions Are Key
Be prepared for technical questions around machinery, production scheduling, or materials handling. Make sure you can confidently explain how you've dealt with these in past experiences or internships. Knowing industry-specific software could also be a big plus!
✨Showcase Your Problem-Solving Skills
Manufacturing environments often focus on continuous improvement. Be ready to discuss specific instances where you’ve solved a production issue or implemented a process improvement. It’s all about demonstrating your analytical thinking and hands-on approach.
✨Align Your Values with Quality and Safety
In a full-time role, companies like Vested Talent value commitment to quality and safety. Be prepared to discuss how you prioritise these factors in your work. It’s about showing that you’re not just looking for a job, but that you genuinely care about contributing positively to their production environment.