Quality Control Specialist

4 weeks ago

Paignton, Torbay, United Kingdom Nissha Medical Technologies Full time

Job Overview
The primary focus of this role is to enhance the 'cost of quality' metrics throughout our manufacturing facility by employing systematic, proactive analysis and enhancement of process efficiencies. This position is responsible for conducting investigations of significant quality issues, utilizing root-cause analysis to identify and implement containment, corrective, and preventive measures.

Core Responsibilities
1. Conduct CAPA investigations;
2. Investigate quality complaints;
3. Lead quality aspects of change management;
4. Perform internal audits in accordance with ISO13485, MDSAP, and regulatory requirements;
5. Assess product and process risks;
6. Validate and approve products and processes;
7. Generate and approve product and material specifications;
8. Assist in the creation of necessary content for technical files;
9. Implement Lean Manufacturing principles such as 5S, OEE, and Right First Time;
10. Maintain procedures, forms, and records pertinent to this role;
11. Manage CAPA processes, conduct root cause analyses, and review risk assessments and action effectiveness;
12. Execute kaizen projects based on complaint trends and departmental feedback;
13. Review FMEA, Control Plans, and CAPA to ensure Risk Priority Numbers are accurate and relevant;
14. Complete product and process validations, ensuring documentation is properly retained and linked to relevant technical files;
15. Oversee Supplier Quality Assurance activities, including approvals and audits;
16. Support the implementation of Lean Management principles in both Quality and Operations;
17. Drive improvements in Cost of Quality metrics, including OEE, CAPA, and complaint reduction.

The responsibilities outlined above are not exhaustive and may evolve as necessary to meet business needs. The job holder may be required to undertake additional duties within the overall scope of the role.

Qualifications

A Bachelor's Degree with a minimum of 3 years of relevant experience (preferably in Medical Devices) is required. Familiarity with Quality Systems and regulatory standards aligned with ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820 is preferred. Experience as an Internal Auditor, ideally with a certified Lead-Auditor qualification.

Skills and Competencies

Strong written and verbal communication skills to facilitate kaizen project implementations. Creative problem-solving and troubleshooting abilities, with proficiency in root-cause analysis using 6σ tools. High proficiency in Microsoft Office, enabling the creation of professional SOPs and WINs. A strong drive and determination to achieve successful outcomes. A positive attitude, enjoyment of teamwork, and eagerness to learn and grow. Ability to effectively collaborate with and influence Operations personnel. Commitment to accountability and ethical practices in all activities.

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