Quality Compliance Engineer

CyDen; Swansea; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Quality Compliance Engineer to ensure adherence to regulatory standards and internal auditing processes. This role involves conducting compliance checks against ISO 13485 and supporting third-party audits, ensuring that the Quality Management System meets industry regulations. The ideal candidate will have a strong attention to detail and excellent communication skills, working independently to maintain high compliance standards. With competitive pay and generous holiday allowances, this position offers a fantastic opportunity for career development in a supportive environment.

Benefits

25 days holiday plus Bank holidays

5% pension contributions

Sick pay

Career development

Employee Assistance Programme

Cycle to Work Scheme

Qualifications

• ISO 13485 certification is essential for this role.
• Knowledge of regulatory compliance checks against ISO 13485, MDSAP, and EU MDR.

Responsibilities

• Conduct internal audits of the Quality Management System.
• Complete regulatory compliance checks and issue audit reports.
• Support third-party regulatory audits and customer audits.

Skills

Auditing Experience to ISO 13485

Knowledge of MDSAP/EU MDR Regulatory requirements

Attention to detail

Good communication skills

Education

ISO 13485 certification

Regulatory requirements training

Job description

Join to apply for the Quality Compliance Engineer role at CyDen.

Overall job purpose:

Internal auditing of the Quality Management System & completing regulatory compliance checks.

Key Responsibilities:

• Adherence to audit schedules for Cyden's Quality Management System and Good Manufacturing Practices (GMP).
• Issuing audit reports and notifications on any follow-up actions identified.
• Monitoring follow-up actions and conducting verification of effectiveness audits.
• Conducting regulatory compliance checks.
• Supporting Third Party regulatory audits and customer audits.
• Completing compliance checks against ISO 13485, MDSAP, and EU MDR for:
• NPI/ECN's
• Customer complaints
• CAPA
• Concessions

Experience:

• Essential: Auditing Experience to ISO 13485/MDSAP/EU MDR.
• Knowledge of MDSAP/EU MDR Regulatory requirements.
• Desirable: Knowledge/experience of NPI/ECN/CAPA/Concession processes.

Qualifications and training:

• Essential: ISO 13485 certification.
• Desirable: Regulatory requirements training, MDSAP/EU MDR Internal Auditing.

Other attributes:

• Great attention to detail.
• Resilience/Tenacity.
• Good communication skills (verbal & written).
• Ability to work with minimal supervision.

In return, we offer competitive pay, 25 days holiday plus Bank holidays (rising to 30 with service), 5% pension contributions, sick pay, career development, Employee Assistance Programme, and Cycle to Work Scheme.

Additional information:

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Consumer Goods