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- Tasks: Ensure quality compliance and continuous improvement in a dynamic engineering environment.
- Company: Join Kinetica, a leading specialist equipment company in Hampshire.
- Benefits: Enjoy competitive pay, opportunities for growth, and a collaborative work culture.
- Why this job: Be part of a team that drives quality standards and makes a real impact in manufacturing.
- Qualifications: Experience in manufacturing or quality engineering, with knowledge of ISO9001 and supplier management.
- Other info: This is a full-time role ideal for mid-senior level professionals.
The predicted salary is between 28000 - 42000 £ per year.
Quality Engineer – Yorkshire, UK – Medical Device – 6-9 Month Contract
About the Company:
We are looking for an experienced Quality Engineer from the medical device industry to start at short notice on a 6 – 9 month contract. The role is site based 5 days a week.
Responsibilities:
- Lead and implement validation programmes, including process, cleaning, sterilisation, and computerised systems validation
- Develop and review validation protocols and reports, ensuring robust statistical analysis and data integrity
- Generate and review equipment qualifications and Gauge R&R studies
- Support site qualification activities aligned to the Master Validation Plan
- Investigate complex quality and compliance issues, driving root cause analysis and CAPA implementation
- Lead risk management activities (e.g. FMEA) and integrate risk processes across the product lifecycle
- Provide quality engineering support to projects, ensuring timely and compliant delivery
- Drive continuous improvement initiatives to enhance systems, processes, and efficiency
- Support maintenance, calibration, and equipment compliance systems
- Participate in internal and supplier audits, ensuring regulatory compliance
Requirements:
- Significant experience working as a Quality Engineer in the medical device industry.
- Availability to start with short notice.
- Ability to work onsite 5 days per week.
- Eligibility to work in the UK for a full duration of the contract.
- Excellent communication skills.
- A good knowledge of ISO 13485.
- Equipment and process qualification and validation experience.
Quality Engineer employer: Kinetica
Contact Detail:
Kinetica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Familiarise yourself with ISO 9001 standards, as this role heavily involves auditing and compliance. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the manufacturing and quality engineering sectors. Attend industry events or join relevant online forums to connect with others who may have insights about Kinetica or similar companies.
✨Tip Number 3
Brush up on your root cause analysis skills, particularly using methodologies like 8D and 5Y. Being able to discuss specific examples of how you've applied these techniques in past roles can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience with cross-functional teams. Highlight instances where you've successfully collaborated with different departments to improve quality processes, as this is a key aspect of the role at Kinetica.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Quality Engineer position. Tailor your application to highlight relevant experience in quality improvement, compliance, and cross-functional program management.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in manufacturing engineering or quality engineering, particularly in electromechanical assembly. Mention specific projects or achievements that demonstrate your expertise in root cause investigation, CAPA, and ISO 9001 auditing.
Showcase Your Skills: Make sure to include key skills mentioned in the job description, such as 8D, 5Y, Lean, and FMEA. Provide examples of how you have applied these methodologies in previous roles to improve quality and compliance.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the company's needs. Discuss your passion for quality assurance and continuous improvement, and explain why you are a great fit for Kinetica's compliance team.
How to prepare for a job interview at Kinetica
✨Know Your Quality Standards
Familiarise yourself with ISO 9001 and other relevant quality standards. Be prepared to discuss how you've applied these standards in your previous roles, especially in relation to equipment calibration and auditing.
✨Demonstrate Problem-Solving Skills
Prepare examples of past experiences where you successfully conducted root cause investigations and implemented CAPA (Corrective and Preventive Actions). Highlight your analytical skills and how they contributed to quality improvement.
✨Cross-Functional Collaboration
Showcase your ability to liaise with different departments. Discuss specific instances where you worked with suppliers or other teams to enhance quality processes, as this is crucial for the role.
✨Highlight Continuous Improvement Initiatives
Be ready to talk about any continuous improvement projects you've led or participated in. Mention methodologies like Lean or FMEA that you've used to drive quality enhancements and how they impacted KPIs.