Quality & Regulatory Affairs (Q&RA) Engineer II
Location: Basingstoke (Remote with 1x month on-site meeting attendance required)
Pay Rate: £27.00 per hour
Contract Duration: 9 months initially (40 hours per week)
Start Date: ASAP
Position Overview
Are you looking to take the next step in your quality career and make a lasting impact on a global scale? We are seeking a high-performing Q&RA Engineer II to join our team. In this role, you will play a vital part in ensuring quality compliance across our operations, helping to deliver life-changing products that make the world healthier, cleaner, and safer.
As a Quality Engineer, you will provide critical quality oversight through detailed documentation reviews, process monitoring, and close cross-functional collaboration. This position is ideal for an experienced professional looking to champion compliance, lead major quality investigations, and drive continuous improvement initiatives.
Key Responsibilities
Compliance & Audits: Support and maintain robust compliance with GMP/GxP, ISO, and global regulatory requirements. Conduct and support both internal and external audits and regulatory inspections.
Investigations & CAPA: Investigate complex quality issues, lead root-cause analysis efforts, and collaborate across departments to drive effective corrective and preventive actions (CAPA).
Documentation & Change Control: Author, review, and approve critical quality documentation (including SOPs and investigation reports) and manage change control activities.
Data & Metrics: Perform advanced data analysis, trending, and reporting of quality metrics to support system enhancements and continuous improvement initiatives.
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 working in highly regulated industries (Pharmaceutical, Medical Device, or Biotech preferred).
Comprehensive experience with Enterprise Quality Management Systems (EQMS), Document Control Systems, CAPA processes, deviation management, and change control.
Demonstrated expertise in advanced root cause analysis, investigation techniques, and corrective action implementation.
Experience actively conducting and hosting internal/external audits and regulatory inspections.
Strong proficiency in statistical analysis, data trending, and quality metrics reporting.
Project management experience is highly preferred.Knowledge, Skills & Abilities:
Deep knowledge of GMP/GxP regulations, ISO standards (such as 9001 and 13485), and other relevant quality system requirements.
Strong grasp of risk assessment methodologies and continuous improvement tools.
Advanced technical writing skills for authoring precise SOPs and investigation reports.
Exceptional problem-solving abilities, high attention to detail, and strong interpersonal/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