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For Companies At a Glance
- Tasks: Oversee quality activities for medical devices, ensuring compliance with ISO13485 standards.
- Company: CPL Life Sciences is a leader in life sciences, focusing on innovative medical device solutions.
- Benefits: Enjoy a dynamic work environment with opportunities for continuous improvement and professional growth.
- Why this job: Join a passionate team dedicated to quality and innovation in healthcare, making a real impact.
- Qualifications: A proactive attitude, strong communication skills, and attention to detail are essential.
- Other info: Experience with eQMS/ERP/PLM systems is preferred; flexibility and teamwork are key.
The predicted salary is between 36000 - 60000 £ per year.
MAIN PURPOSE
CPL Life Sciences are seeking a skilled and experienced quality specialist to oversee the quality activities related to medical device products with a focus on IVD kits, procedure packs and medical devices supporting the setup and ongoing compliance to ISO13485 and relevant standards and regulations.
Duties and Responsibilities
- Quality Management System: Develop, implement, and maintain the QMS in accordance with applicable standards and regulations. Ensure continuous improvement of the QMS, processes, procedures relevant and adoption of best practice. Participate & contribute as an auditee & member of the auditee team for external audits.
- Verification & Validation: Oversee the validation processes involved in the validation of processes, systems and equipment. Analyse, Plan, Specify and Execute verification and validation activities for Products, Packaging and Manufacturing Equipment. Record test failures and deviations. Identify V&V needs/gaps/opportunities within the business. Engage effectively with key stakeholders (e.g. Engineering, RA etc). Communicate timeously with Quality and Functional leaders. Produce Test reports, supervise approval process. Initiate continuous improvements to the V&V process. Utilise eQMS as appropriate.
- Risk Management: Conduct risk assessments and xFMEA to manage risks and develop mitigation strategies. Oversee the risk management process. Utilise eQMS as appropriate. Communicate timeously with Quality and Functional leaders. Communicate residual risks to Quality and Functional leaders. Produce Risk Management documentation.
- Supplier Management: Review and assessment of suppliers, audit where applicable. Perform and complete supplier performance ratings and risk ratings. Issue SCAR’s (Supplier Corrective Action Requests) as required. Collaborate cross-functionally on Supplier Management processes.
- Audit Management: Perform internal audits to ensure compliance with the requirements of ISO13485 and applicable standards, regulations and business procedures. Manage as part of team external assessment and audits for ISO13485 and applicable standards, regulations and business procedures. Address audit non-conformances as necessary.
COMPETENCY REQUIREMENTS
- A positive, pro-active can-do attitude.
- Communicate clearly with strong and adaptable interpersonal skills.
- Authority to reject product and documentation that does not meet requirements.
- Be a strong ambassador for Quality culture and mindset.
- Honest, trustworthy and reliable – demonstrate integrity.
- Time management and ability to prioritise tasks to ensure customer and business needs are met.
- Flexibility and adaptability to a dynamic and growing business.
- Have strong attention to detail with the ability to take a holistic view when appropriate.
- Remain calm and upbeat even in difficult circumstances, always looking for continuous improvement.
- Self-motivated and able to perform as part of a team, supporting their colleagues when required.
- Strong verbal and written communication skills.
- Working knowledge MS Office and Outlook.
- Preferably with: Knowledge and experience with eQMS/ERP/PLM systems.
- Essential: Follow Company Quality, Environmental and Health & Safety Procedures.
For more information, apply with your updated CV or send a message to.
Quality Specialist employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist
✨Tip Number 1
Familiarise yourself with ISO13485 and other relevant standards. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality management in the medical device industry.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those who work with medical devices. Engaging with industry experts can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality management systems in previous roles. Highlighting your experience with verification and validation processes will set you apart from other candidates.
✨Tip Number 4
Showcase your problem-solving skills by preparing for scenario-based questions. Be ready to explain how you would handle audit non-conformances or improve existing processes, as this reflects your proactive approach to quality.
We think you need these skills to ace Quality Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management systems, particularly with ISO13485 and medical devices. Use specific examples that demonstrate your skills in verification, validation, and risk management.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your motivation for applying to the Quality Specialist position. Emphasise your proactive attitude and ability to communicate effectively with cross-functional teams, as these are key competencies for the role.
Showcase Relevant Skills: In your application, highlight your experience with eQMS, supplier management, and audit processes. Mention any specific tools or methodologies you have used, such as xFMEA, to manage risks and improve quality.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Specialist.
How to prepare for a job interview at Cpl Life Sciences
✨Understand ISO13485 Standards
Familiarise yourself with ISO13485 and other relevant standards before the interview. Be prepared to discuss how you have implemented or maintained a Quality Management System in previous roles, as this will demonstrate your expertise and understanding of the requirements.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified gaps in verification and validation processes and the steps you took to address them. Highlighting your analytical skills and ability to implement continuous improvements will resonate well with the interviewers.
✨Communicate Effectively
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Be ready to explain complex quality concepts in simple terms, as you may need to engage with stakeholders from various departments.
✨Demonstrate a Proactive Attitude
Exhibit your positive, can-do attitude during the interview. Share instances where you took the initiative to improve quality processes or resolve issues, showcasing your commitment to fostering a quality culture within the organisation.
