At a Glance
- Tasks: Ensure product quality by reviewing Device History Records and maintaining compliance standards.
- Company: Join a leading medical device company in Birmingham with a focus on quality and innovation.
- Benefits: Competitive pay, full-time hours, and opportunities for professional growth.
- Other info: Dynamic team environment with a commitment to diversity and equality.
- Why this job: Be a key player in ensuring high-quality medical devices that make a difference.
- Qualifications: GCSEs in English, Maths, and Science; experience in the medical device industry preferred.
The predicted salary is between 13.94 - 13.94 £ per hour.
We are seeking a Sr QA Technician (Batch Release) to join our team in Birmingham. In this role, you will be responsible for performing batch release activities, ensuring regulatory compliance, verifying Device History Records (DHRs), and maintaining high quality standards. You will serve as a key point of contact for GXP documentation and support ongoing quality management initiatives.
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 (GxP, GMP, GDP, MDSAP, IVDR).
- Process Improvement: Participate in continuous improvement projects, QA standardization 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 GxP standards, specifically GMP, GDP, MDSAP, and IVDR.
- Technical Skills: Proficiency in Microsoft Office (Forms, Teams, SharePoint) and familiarity with quality management systems like MasterControl.
- 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. 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.
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