At a Glance
- Tasks: Ensure quality standards and compliance in batch release activities for medical devices.
- Company: Join a leading company in the medical device industry based in Birmingham.
- Benefits: Competitive pay, full-time hours, and opportunities for professional growth.
- Other info: Collaborative team culture with a focus on continuous improvement and career development.
- Why this job: Make a real impact on product quality and patient safety in a dynamic environment.
- Qualifications: 5 GCSEs including English, Maths, and Science; experience in the Medical Device Industry.
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 (Gx P, 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 analyze 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 prioritize 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.
Sr Administrative/QA Technician in Birmingham employer: Jobiqo
Bromley Council is an exceptional employer, dedicated to fostering a supportive and inclusive work environment where employees can thrive. With a strong commitment to professional development, flexible working arrangements, and a generous benefits package, including a local government pension scheme and unique discounts, the Council prioritises employee well-being and career growth. Located in the vibrant Bromley Civic Centre, you will be part of a team that plays a crucial role in shaping the future of the borough while enjoying the balance of urban and suburban life.
