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- Tasks: Join our Quality team to ensure compliance with medical device regulations and quality standards.
- Company: We specialize in manufacturing high-quality medical devices that save lives.
- Benefits: Enjoy a collaborative work environment with opportunities for continuous improvement and professional growth.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and passionate professionals.
- Qualifications: Bachelor’s degree in Engineering or Life Sciences and 3 years of relevant experience required.
- Other info: No sponsorship available; applicants must have full right to work.
The predicted salary is between 36000 - 60000 £ per year.
Position Overview:
We are seeking a Quality Specialist with at least 3 years of experience to join our Quality team in ensuring compliance with medical device regulations and quality standards. The role involves supporting quality assurance and control activities across manufacturing processes for medical device products.
*** No sponsorship available, only available to those with full right to work ***
Key Responsibilities:
- Implement and maintain Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
- Conduct inspections, testing, and release activities for components and finished medical device products.
- Support internal and external audits, including preparation, participation, and follow-up on corrective actions.
- Collaborate with cross-functional teams to address non-conformities, deviations, CAPAs, and complaints to drive resolution and compliance.
- Assist in the validation of manufacturing processes, equipment, and software (IQ/OQ/PQ).
- Review and approve batch records, change control documents, and quality-related documentation.
- Maintain and update quality records, including product inspection reports, NCR logs, and calibration schedules.
- Support risk management processes (ISO 14971) and ensure adherence to design control requirements.
- Train staff on quality standards, procedures, and best practices.
- Monitor trends, metrics, and KPIs to identify and implement continuous improvement opportunities.
Required Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 3 years of experience in quality assurance or quality control within a medical device environment (CMO experience preferred).
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
- Experience with CAPA, non-conformance investigations, and root cause analysis.
- Familiarity with validation protocols (IQ/OQ/PQ) and risk management principles (ISO 14971).
- Proficiency in MS Office Suite; experience with QMS software is a plus.
- Strong analytical, problem-solving, and communication skills.
Preferred Qualifications:
- Experience with Class I, II, or III medical devices manufacturing.
- Knowledge of sterilization processes, packaging validation, or cleanroom environments.
- Internal auditor certification (ISO 13485) or other quality certifications (e.g., CQPA, CQE) are a plus.
Quality Specialist employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist
✨Tip Number 1
Make sure to familiarize yourself with ISO 13485 and FDA 21 CFR Part 820 regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device industry.
✨Tip Number 2
Highlight any experience you have with CAPA processes and non-conformance investigations. Be ready to discuss specific examples of how you've successfully resolved issues in previous roles, as this is crucial for the Quality Specialist position.
✨Tip Number 3
Network with professionals in the medical device field, especially those who work in quality assurance. Engaging with others can provide insights into the company culture and expectations, which can be beneficial during your application process.
✨Tip Number 4
Prepare to discuss your experience with validation protocols (IQ/OQ/PQ) and risk management principles (ISO 14971). Being able to articulate your knowledge in these areas will set you apart from other candidates.
We think you need these skills to ace Quality Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in quality assurance and control, especially within the medical device industry. Emphasize your knowledge of ISO 13485 and FDA regulations.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality management and detail how your background aligns with the responsibilities listed in the job description. Mention specific experiences that demonstrate your problem-solving skills and ability to collaborate with cross-functional teams.
Highlight Relevant Certifications: If you have any certifications related to quality management, such as ISO 13485 or CQE, be sure to mention them prominently in your application. This can set you apart from other candidates.
Showcase Continuous Improvement Initiatives: Provide examples of how you've contributed to continuous improvement in previous roles. Discuss any metrics or KPIs you monitored and how your actions led to positive changes in quality processes.
How to prepare for a job interview at Arevna
✨Know Your Regulations
Make sure you have a solid understanding of ISO 13485 and FDA 21 CFR Part 820. Be prepared to discuss how you've applied these regulations in your previous roles, as this will demonstrate your expertise and readiness for the position.
✨Showcase Your Experience
Highlight your experience in quality assurance or control within a medical device environment. Be ready to provide specific examples of how you've handled CAPA, non-conformance investigations, and root cause analysis.
✨Prepare for Technical Questions
Expect technical questions related to validation protocols (IQ/OQ/PQ) and risk management principles (ISO 14971). Brush up on these topics and be ready to explain your approach to ensuring compliance and quality.
✨Demonstrate Collaboration Skills
Since the role involves working with cross-functional teams, be prepared to discuss how you've collaborated with others to address non-conformities and drive resolutions. Share examples that showcase your communication and teamwork abilities.
