At a Glance
- Tasks: Ensure quality compliance and drive improvements for life-changing products.
- Company: Join a collaborative team making a global impact.
- Benefits: Competitive pay, remote work, and professional growth opportunities.
- Other info: Diverse environment with a focus on equality and support.
- Why this job: Be part of innovative solutions tackling the world's toughest challenges.
- Qualifications: Degree in Life Sciences or Engineering with relevant experience.
Location: Basingstoke (Remote with 1x month on-site meeting attendance)
Pay Rate: £23.50 per hour
Contract Duration: 9 months initially (40 hours per week)
Start Date: ASAP
Position Overview
Are you looking to make a meaningful impact on a global scale? We are seeking two high-performing Q&RA Engineers to join a collaborative team dedicated to developing solutions for some of the world's toughest challenges. In this role, you will ensure quality compliance across operations, providing essential quality oversight through detailed documentation reviews, process monitoring, and close collaboration with cross-functional teams. This is a fantastic opportunity to maintain compliance, investigate quality events, and drive continuous improvement initiatives for life-changing products.
Key Responsibilities
- Compliance & Audits: Support and maintain compliance with GMP/GxP, ISO, and regulatory requirements. Conduct and support internal/external audits and regulatory inspections.
- Investigations & CAPA: Investigate quality issues, lead root-cause analysis efforts, and collaborate across teams to drive corrective and preventive actions (CAPA).
- Documentation & Change Control: Author and review critical quality documentation (SOPs, investigation reports, etc.) and manage change control activities.
- Data & Metrics: Perform data analysis, trending, and reporting of quality metrics to support continuous improvement.
Requirements & Qualifications
- Education: Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of experience in QA/QC OR an Advanced degree with 3+ years of relevant experience.
- Experience: Proven background in regulated industries (Pharmaceutical, Medical Device, or Biotech preferred). Hands-on experience with Quality Management Systems (e.g., Document Control Systems), CAPA processes, deviation management, and change control. Demonstrated expertise in root cause analysis and investigation techniques. Experience conducting and hosting internal/external audits. Proficiency in statistical analysis, data trending, and quality metrics reporting. Project management experience is highly preferred.
- Knowledge, Skills & Abilities: Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485). Familiarity with risk assessment methodologies and continuous improvement tools. Excellent technical writing skills for authoring SOPs and investigation reports. Advanced problem-solving abilities, high attention to detail, and excellent communication skills. Ability to work independently, guide cross-functional teams, and work in manufacturing environments with appropriate PPE as needed.
Interview Process
Stage 1: 30-minute initial interview. Note: A standard background check is required for the successful candidate.
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.
Q& RA Engineer I employer: Randstad Engineering
Join a forward-thinking team in Basingstoke as a Quality & Regulatory Affairs Engineer I, where you will play a crucial role in ensuring compliance and driving quality improvements for life-changing products. Our company fosters a collaborative work culture that values diversity and offers flexible remote working options, alongside opportunities for professional growth and development in the regulated industries. With a commitment to making a meaningful impact on a global scale, we provide our employees with the tools and support needed to excel in their careers while contributing to innovative solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Q& RA Engineer I
✨Tip Number 1
Network like a pro! Reach out to folks in the Q&RA field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for those interviews! Research the company and its products, and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. It’s all about Situation, Task, Action, and Result. This will help you articulate your past experiences clearly and effectively.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of resources to help you ace your application and get noticed by hiring managers. Let’s land that job together!
We think you need these skills to ace Q& RA Engineer I
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Q&RA Engineer role. Highlight your experience in quality compliance, audits, and documentation. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality and regulatory affairs. Share specific examples of how you've tackled challenges in previous roles.
Showcase Your Technical Skills:Don’t forget to mention your technical writing skills and experience with Quality Management Systems. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Randstad Engineering
✨Know Your Regulations
Make sure you brush up on GMP/GxP and ISO standards before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and are ready to contribute from day one.
✨Prepare for Technical Questions
Expect questions about your experience with Quality Management Systems and CAPA processes. Be ready to share specific examples of how you've handled quality issues or conducted audits in the past, as this will demonstrate your hands-on experience.
✨Showcase Your Problem-Solving Skills
During the interview, highlight your advanced problem-solving abilities. Discuss a challenging situation you faced, how you approached it, and what the outcome was. This will illustrate your analytical skills and ability to drive continuous improvement.
✨Communicate Clearly
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly and concisely. Whether discussing technical writing or collaboration with cross-functional teams, being able to convey your ideas effectively will set you apart.
