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Quality Assurance Manager
2 months ago
Job Title: Quality Assurance Manager
Company: SPD Development Company Ltd
Location: Bedford, UK (with option for Hybrid Working)
Job Type: Full-Time, Permanent
Job SummaryWe are seeking an experienced Quality Assurance Manager to join our Quality team at SPD Development Company Ltd. The successful candidate will be responsible for ensuring the adequacy, effectiveness, and continuous improvement of our Quality Management System.
Key Responsibilities- Document Control and Standards Monitoring: Ensure that all quality-related documents are up-to-date, accurate, and compliant with regulatory requirements.
- CAPA & Non-conformances: Investigate and resolve non-conformances, and implement corrective actions to prevent recurrence.
- Internal and External Audits: Plan, conduct, and report on internal and external audits to ensure compliance with regulatory requirements.
- Risk Management: Identify, assess, and mitigate risks to the quality management system.
- Computer System Verification: Verify the accuracy and reliability of computer systems used in the quality management system.
- Training: Provide training to employees on quality-related procedures and regulatory requirements.
- Experience: Proven experience in a quality assurance role, preferably in a medical device environment.
- Knowledge: Sound knowledge of ISO 13485:2016, US FDA 21 CFR 820, and ISO 14971:2019.
- Qualifications: Lead Auditor qualification or equivalent experience.
- Skills: Excellent communication and interpersonal skills, with the ability to adapt to different audiences.
- Hybrid Working: Option for Hybrid Working.
- Annual Leave: 25 days paid annual leave plus bank holidays (pro-rata).
- Pension Scheme: Company pension scheme including competitive employer's contribution.
- Private Medical Insurance: Private Medical Insurance package with additional medical cash plan scheme.
- Enhanced Maternity and Paternity Pay: Enhanced maternity and paternity pay.
- Health & Wellbeing Programme: Company supported employee Health & Wellbeing programme.
- Life Assurance: Life assurance.
- Free Electrical Car Charging Points: Free electrical car charging points.
