Quality Engineer

Job Description

We have an exciting opportunity for a Quality Systems Engineer to join our Quality team based at our offices in Kingswinford, West Midlands. This role is a full time on-site role.

The purpose of this role is to ensure the Quality Management System is established and maintained in line with regulatory and certification requirements. Support ongoing departmental / process audits to ensure conformance to external and internal quality practises, policies, and procedures.

The job role is best suited to a well-organised, detail-orientated person with experience in the medical device sector and implementation of quality system procedures. Someone who can identify regulatory/quality issues and liaise with departmental managers to establish improvements.

Core Responsibilities;

• Take responsibility for the internal audit program; leading / reporting of internal QHSE / ad-hoc process audits and maintenance / adherence of the internal audit schedule.
• Scheduling external audits to ensure company certifications are maintained.
• Act as quality representative for certification / surveillance audits including FDA 21 CFR Part 820, ISO 13485, ISO 9001, ISO 14001, and ISO 45001.
• Responsible for timely Medical Device Reporting through the FDA electronic submissions gateway.
• Support the Quality Manager with the evaluation of feedback / complaints for medical device reporting requirements.
• Take ownership of the document control process and maintenance/processing of documentation in line with quality system and FDA Part 11 requirements. Continue ongoing improvements to the system alongside company training.
• Drive the documentation, investigation, corrective action, verification and closure of quality issues and audit findings through the NCR and CAPA process, ensuring correct documentation and regular communication with NCR and CAPA owners to drive close-out.
• Maintain the company’s Business Management Systems ensuring compliance to ISO 9001, FDA 21 CFR Part 820 and Part 11.
• Actively work towards the implementation of ISO 13485; liaising with global sites to work towards global procedures.
• To locally implement and monitor Group QHSE Policies and Processes, ensuring embedding and approval of all QHSE documents.
• Cross UK site systems and audit support as required.
• Support collection and presentation of KPIs for Non-Conformance, CAPA and Internal Audits.
• Collation of data and presentation for annual management reviews of the QHSE Management Systems, ensuring the company risk register is reviewed and updated with input from departmental managers.
• Maintenance of Quality training matrix; ensuring new training records are signed when new document revisions are released.
• Deliverance of Quality Inductions for new recruits.

Requirements:

• ISO 13485 audit training
• ISO 9001 auditor training
• Experience and knowledge of FDA 21 CFR Part 820 (FDA Quality System Regulations), Part 803 (Medical Device Reporting), ISO 13485 and ISO 14971 requirements.
• Experience implementing and maintaining quality systems
• Experience leading root cause investigations
• Experience as Lead Auditor
• Knowledge and experience of ISO 9001
• Excellent interpersonal skills at all business levels
• Good presentation/ communication skills
• Good at prioritising and managing high workload
• Analysing and interpreting data with good reporting skills
• Experience of regulated industry

Desirable

• ISO 45001 / 14001 audit training
• Any medical-device specific training, e.g. design control, validation, etc.
• Excellent IT skills, able to analyse ‘big data’.

We are a passionate and friendly team of people who care deeply about Making Everyday Life Easier for our customers and if you think you could make a positive difference in our business, we would love to hear from you!

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