Quality & Regulatory Engineer II

Location: Basingstoke (Remote / 1x Month Onsite) Pay Rate: £27.00 per hour Hours: 40 hours per week (Monday - Friday) Contract Duration: 9 Months initially

Are you a technical Quality professional with a passion for compliance, data integrity, and continuous improvement?

We are seeking a Q&RA Engineer II to join our team on an initial 9-month remote contract. This high-level role is ideal for a self-driven engineer who thrives on technical problem-solving, detailed documentation review, and cross-functional collaboration within highly regulated manufacturing environments.

Key Responsibilities:

Compliance Management: Maintain and support strict compliance with global GMP/GxP regulations, ISO 9001/13485 standards, and internal quality system metrics.

Investigations & CAPA: Lead root cause analysis (RCA) efforts for localized quality events and deviations, implementing robust corrective and preventive actions.

Change Control & Auditing: Manage day-to-day change control workflows, update internal documentation (SOPs, investigation logs), and support internal and external quality audits.

Data Trending: Perform statistical analysis, quality metric reporting, and trend mapping to drive operational excellence.

Requirements:

Education: Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field.

Experience: 5+ years of quality assurance/control (QA/QC) experience in a regulated setting (Pharmaceutical, Medical Device, or Biotech strongly preferred).

Systems: Solid proficiency with electronic Quality Management Systems (eQMS) such as MasterControl or TrackWise.

Skills: Strong technical writing skills for authoring regulatory compliance logs, advanced problem-solving abilities, and the capacity to work independently.

What We Offer:

Work-Life Balance: A primarily work-from-home, autonomous schedule requiring only one travel day per month to our Basingstoke site.

Fast-Track Process: A streamlined interview cycle consisting of a single, 30-minute conversation with the hiring manager.

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
Only candidates based in UK and eligible to work in UK are allowed