Quality Assurance Supervisor (Compliance)

AccuBio Ltd; Alva; On-site; GBP 42,000 - 51,000; Full time

Job summary

A leading company in the in-vitro diagnostics sector is seeking a Quality Assurance Supervisor to oversee quality strategy implementation and ensure compliance with industry standards. The role involves managing audits, training, and fostering a positive work environment. Candidates should possess a Life Science degree and significant QA experience in regulated industries. This is a permanent, full-time position based in Alva.

Qualifications

• Minimum 5 years' experience in Quality Assurance in medical or in-vitro device manufacturing.
• Understanding of MDR, IVDR, and ISO standards.

Responsibilities

• Lead the development and implementation of the site quality strategy.
• Manage the site audit programme and quality training programme.
• Ensure compliance with cGMP, ISO 13485, and other standards.

Skills

Leadership

Communication

Attention to detail

Time management

Education

Life Science Degree

Tools

Microsoft Excel

Visio

Adobe Acrobat

EQMS

Job description

Quality Assurance Supervisor (Compliance)

Location: Alva, Clackmannanshire - FK12 5DQ
Salary: GBP42,138 - GBP50,767 per annum DOE plus benefits
Contract: Permanent, Full time

AccuBio Ltd. (manufacturers of In vitro Medical Devices) is currently recruiting for a Quality Assurance Supervisor (Compliance).

Job Purpose:

As our Quality Assurance Supervisor, your overall job purpose is to lead the development and implementation of the site Quality Strategy that complies with all relevant quality bodies, standards, and directives, contributing to the UK vision and strategic objectives.

You will plan and coordinate the activities required to meet quality standards and ensure compliance with industry standards.

Responsibilities:

Main Areas:

• Lead the development and implementation of the site quality strategy compliant with all relevant external standards and directives.
• Fulfill the requirements of the site Quality Management Representative and PRRC role.
• Maintain current knowledge of IVDD/R industry developments and relevant quality standards and directives; recommend changes to the President.
• Lead, plan, and manage the site audit programme (internal and external).
• Lead, plan, and manage the site quality training programme.
• Create a positive working environment in the quality department to foster employee engagement and continuous improvement.
• Monitor quality KPIs and implement strategies to meet targets.
• Manage quality department expenditure within budgets.
• Collaborate with R&D, commercial, and operations teams regarding product development and customer requirements.
• Develop and maintain professional relationships with colleagues, customers, and third parties.
• Contribute to the development and implementation of site and company strategic objectives with the Senior Management Team.
• Maintain quality requirements from external suppliers and work with supply chain.
• Maintain the quality management system through documentation control.
• Monitor corrective and preventive actions and nonconforming products.
• Ensure compliance with cGMP, ISO 13485, and other standards.
• Manage customer complaints, vigilance reporting, and field actions.
• Risk management owner.
• Oversee post-marketing surveillance activities.

People Management Responsibilities:

• Lead by example, demonstrating good HR practices and people management.
• Motivate staff through regular PDRs, training, and development.

General Responsibilities:

• Perform duties to company standards within required timescales.
• Ensure compliance with Health & Safety, QMS, GDPR, and Cyber Security policies.
• Perform other duties as required.

Knowledge, Skills & Experience:

Essential:

• Life Science Degree.
• Minimum 5 years' experience in Quality Assurance in medical or in-vitro device manufacturing.
• Understanding of MDR, IVDR, and ISO standards.
• Proficiency with core IT packages, especially Microsoft Excel, Visio, Adobe Acrobat, EQMS.
• Excellent written English and communication skills.
• Ability to motivate, develop staff, and lead by example.
• Highly motivated and energetic.
• Ability to work under pressure and meet deadlines.
• Attention to detail and good report writing skills.
• Effective time management and prioritization skills.

Desirable:

• Internal and Lead Auditor experience, risk management.
• Supervisory experience in QA within regulated industries.
• Familiarity with Q-Pulse.

About us:

AccuBio is a UK-based company (2022), wholly owned by Zhejiang Orient Gene Biotech, founded in 2005. Our vision is to be a leader in global in-vitro diagnostics, integrating science and technology to support health diagnosis and life.

Core values:

• Continuous Innovation
• Customer Orientation
• Challenge the Impossible
• Grow Together

Due to high application volume, we cannot respond to all applicants. If you do not hear from us within four weeks, please consider your application unsuccessful.

If you believe you have the necessary skills and experience, click on APPLY today and send your updated CV for consideration.

No agencies please.