Job Purpose Summary
The Quality Engineer supports the Quality Assurance function at the Solihull site, contributing to the execution of quality and regulatory activities in line with business and compliance requirements. The role focuses on completing post‑market surveillance, quality system, and continuous improvement activities to support product quality, patient safety, and regulatory compliance.
This is a hybrid position; 4 days per week will need to be onsite in our offices in Solihull.
What You Will Do
* Quality Management System (QMS) – Support the maintenance and continuous improvement of the QMS in line with ISO 13485 and regulatory requirements.
* Post‑Market Surveillance – Perform post‑market activities including complaint handling, adverse event reporting, and supporting investigations in line with defined processes.
* Complaint & Investigation Support – Conduct initial investigations, gather data, and collaborate with cross‑functional teams to support root cause analysis and resolution.
* Non‑Conformance & CAPA – Support the execution of non‑conformance and CAPA activities, including documentation, tracking, and effectiveness checks.
* Internal Audits – Participate in internal audits in line with the audit plan and support follow‑up actions.
* Quality Engineering Activities – Prepare and review validation documentation, engineering studies, and investigation reports.
* Supplier & Incoming Quality – Support incoming inspection and supplier quality monitoring activities, including data collection and reporting.
* Sterilisation & Release – Support review of sterilisation documentation and product release activities in line with QMS requirements.
* Cross‑functional Support – Work with site and global teams to support regulatory, validation, and quality improvement initiatives.
* Continuous Improvement – Contribute to initiatives that improve product quality, compliance, and operational performance.
What You Will Need
* HNC/HND or Degree in Engineering (Mechanical, Manufacturing, or related discipline) or equivalent experience.
* Relevant quality or regulatory training (e.g. ISO 13485 auditor training desirable).
* Experience within a medical device or regulated manufacturing environment.
* Strong knowledge of QMS standards (ISO 13485, FDA QSR).
* Understanding of CAPA, non‑conformance, and root cause analysis.
* Ability to review and produce technical documentation (validation, investigations).
* Strong communication skills across multiple levels of the organisation.
What we value
* Customer First – We deliver extraordinary experiences.
* Accountability – We do what we say.
* Integrity – We do what is right.
* Inspired – We love what we do.
* One Global Team – We before me, always.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
#J-18808-Ljbffr