Quality Compliance Engineer

TN United Kingdom; Swansea; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a detail-oriented Quality Auditor to ensure compliance with ISO 13485 and regulatory standards. This role involves auditing the Quality Management System, conducting regulatory compliance checks, and supporting third-party audits. With a focus on continuous improvement, you'll play a vital role in maintaining high standards of quality and compliance. The company values diversity and offers a supportive environment with competitive pay and numerous benefits, including generous holiday allowances and career development opportunities.

Benefits

25 days holiday plus bank holidays

5% company pension contributions

Sick pay

Career development opportunities

Employee Assistance Programme

Cycle to Work Scheme

Qualifications

• Experience in auditing against ISO 13485 and regulatory standards.
• Certification in ISO 13485 and training in regulatory requirements.

Responsibilities

• Adhere to audit schedules for Quality Management System.
• Conduct regulatory compliance checks and support audits.

Skills

Auditing experience to ISO 13485

Knowledge of MDSAP/EU MDR regulatory requirements

Experience with NPI/ECN/CAPA/Concession processes

Attention to detail

Ability to work independently

Education

ISO 13485 certification

Regulatory requirements training

MDSAP/EU MDR internal auditing

Job description

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Internalauditing of the Quality Management System & completing regulatory compliance checks.

Key Responsibilities:

1. Adherence to audit schedules for Cyden's Quality Management System and Good Manufacturing Practices (GMP)
2. Issuing audit reports and notifications on follow-up actions
3. Monitoring follow-up actions and conducting verification of effectiveness audits
4. Conducting regulatory compliance checks
5. Supporting third-party regulatory audits and customer audits
6. Completing compliance checks against ISO 13485, MDSAP, and EU MDR for:

• NPI/ECN's
• Customer complaints
• CAPA
• Concessions

Note: These tasks are not exhaustive. The post holder is expected to perform any reasonable duties as assigned by their Line Manager to support business needs. Specific responsibilities and authorities are outlined in relevant procedures.

Experience:

• Auditing experience to ISO 13485, MDSAP, and EU MDR
• Knowledge of MDSAP/EU MDR regulatory requirements
• Experience with NPI/ECN/CAPA/Concession processes

Qualifications and Training:

• ISO 13485 certification
• Regulatory requirements training
• MDSAP/EU MDR internal auditing

Other Attributes:

• Great attention to detail
• Completer/Finisher mindset
• Ability to work independently

Benefits:

We offer competitive pay, 25 days holiday plus bank holidays (rising to 30 with service), 5% company pension contributions, sick pay, career development opportunities, Employee Assistance Programme, and Cycle to Work Scheme.

CyDen is committed to being an equal opportunity employer and values diversity.