Quality Systems Associate

Urgent

Job Description

Quality Systems Associate

Location: Office based, Alva, Clackmannanshire – FK12 5DQ
Salary: £24,474 – £28,711 per annum, DOE plus benefits
Contract: Permanent, Full time
Hours: Monday Thursday 8.30am-5pm Friday 8.30am-2.30pm

AccuBio Ltd. (manufacturers of In vitro Medical Devices) are currently recruiting for a Quality Systems Associate.

Job Role:

As our Quality Systems Associate your main role is to coordinate the organisation s activities required to meet quality standards and compliance to industry requirements.

Main Responsibilities:

• Maintain the company’s quality procedures, standards and specifications.
• Review completed documentation to ensure completeness, accuracy and data integrity.
• Review and maintain customer requirements in relation to the company’s quality procedures, standards and specifications.
• Liaise with strategic sourcing staff to implement quality requirements from external suppliers.
• Assist with quality procedures and requirements in conjunction with operating staff.
• Maintain the quality management system via controlling documentation and records.
• Monitor the organisation s quality performance by gathering relevant data.
• Monitor and progress of corrective and preventive action activities, complaint handling and the handling of nonconforming product and provide support and assistance as required.
• Review existing policies, make suggestions for changes and improvements and their effective implementation.
• Monitor the effectiveness of changes made and provide support as required.
• Advise Managers and Staff of the most appropriate quality processes to utilise that align with the group s quality goals and culture.
• Advise Managers and Staff to conduct all work activities to maintain compliance with cGMP and other relevant quality standards.
• Assist in training staff across the organisation on internal quality orientated processes and culture.

General Areas of Responsibility:

• Carry out all duties and responsibilities to the company standard within the timescales required.
• Maintain compliance with Health & Safety policies and procedures.
• Maintain compliance with QMS policies and procedures.
• Maintain compliance with GDPR and Cyber Security policies and procedures.
• Perform any other reasonable duties and responsibilities as required

Knowledge, Skills & Experience:

Essential:

• A relevant degree or equivalent professional qualification
• Minimum of one year s experience in a similar Quality Assurance role
• Strong organisational and administrative skills
• Proficient in both written and verbal communication
• Effective time management and prioritisation skills
• High attention to detail with a systematic and methodical approach to work
• Ability to work well under pressure, meet deadlines and adapt to changing priorities
• Self-motivated and capable of working independently or within a team

Desirable:

• Experience within the medical device sector or a similarly regulated industry

About us:

AccuBio is a UK based company (2022), wholly owned by Zhejiang Orient Gene Biotech, who were formed in 2005. Our company vision is to become a great enterprise in the field of global in-vitro diagnostics, that integrates global science and technology to provide health diagnosis and support for life.

Core values:

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

Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks please assume that your application has been unsuccessful.

If you feel you have the necessary skills and experience to be successful in this role click on APPLY today, forwarding an up to date copy of your CV for consideration in the first instance.

No agencies please.

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