At a Glance
- Tasks: Review device history records and ensure compliance for product batch release.
- Company: Join a leading company in the medical device industry with a focus on quality.
- Benefits: Earn £13.94 per hour with full-time hours and opportunities for growth.
- Other info: Dynamic team environment with a commitment to diversity and inclusion.
- Why this job: Make a real impact on product quality and safety in healthcare.
- Qualifications: 5 GCSEs including English, Maths, and Science; experience in the medical device sector.
The predicted salary is between 13.94 - 13.94 £ per hour.
Key Responsibilities
- Batch Release & DHR Review: Review Device History Records (DHRs) following ALCOA+ principles to verify compliance with Device Master Records (DMRs), manufacturing procedures, and ERP information.
Ensure Quality Events, Non‑Conformance Reports (NCRs), and CAPAs are resolved prior to product batch release.
- Quality & Compliance: Maintain procedural and regulatory compliance (Gx P, GMP, GDP, MDSAP, IVDR).
- Process Improvement: Participate in continuous improvement projects, QA standardisation activities, and batch review/release documentation revisions.
- Collaboration & Communication: Work closely with cross‑functional teams, participate in training initiatives, and present quality‑related information.
- KPI & Metrics Tracking: Collate and communicate key performance indicators (KPIs) to monitor operational quality and analyse trends.
- Role Details
- Location: Birmingham (Onsite)
- Employment Type: Full‑time (40 hours/week)
- Contract Duration: 6 months
- Shift Pattern: Monday–Friday, 08:30 – 17:00
- Pay Rate: £13.94 per hour
Requirements & Qualifications
- Education: Minimum 5 GCSEs (Grade 5 or above, or equivalent), including English, Maths, and Science.
- Experience: Previous experience in the Medical Device Industry.
- Regulatory Knowledge: Sound knowledge of Gx P standards, specifically GMP, GDP, MDSAP, and IVDR.
- Technical Skills: Proficiency in Microsoft Office (Forms, Teams, Share Point) and familiarity with quality management systems like Master Control.
- Soft Skills: Excellent oral/written communication, problem‑solving skills, strong attention to detail, project management capability, and the ability to prioritise workload.
- Other: Ability to complete a standard background check and travel off‑site within a 20‑mile radius on rare occasions.
Randstad CPE values diversity and promotes equality.
No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010.
We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
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Sr QA Technician in Birmingham employer: Randstad Construction & Property
Randstad Construction & Property is an excellent employer, offering a supportive work culture that prioritises employee development through extensive training and clear progression pathways. Located in Croydon, the hybrid working model allows for flexibility while being part of a dynamic team dedicated to excellence in financial functions.
Contact Details:
Randstad Construction & Property Recruitment Team
