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Position: Quality Engineer
Location: Near Colchester, UK (fully on-site)
Client: Medical Equipment Manufacturing
Planet Pharma are partnered with a global UK-based medical devices company, who are currently hiring on a permanent basis for a Quality Engineer to join their team based near Colchester.
Main Responsibilities:
* Support validation and verification processes to define inspection criteria and ensure timely project completion.
* Assist in maintaining product Technical Files with the Regulatory Affairs Manager.
* Maintain and improve the Quality Management System (QMS).
* Lead problem-solving and change management activities across development and production.
* Support internal and supplier audits, ensuring effective follow-up actions.
* Promote quality awareness across the business through training and coaching.
The successful candidate will have the following:
* Experience in Quality Assurance systems and tools, ideally in medical devices
* Strong knowledge of ISO13485, ISO9001, MDD/MDR, CFR Part 820 & ISO14971
* Skilled in quality techniques: FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, statistics
* Engineering background with high attention to detail
* Organised, methodical, and able to manage workload independently
* Confident interacting with all levels of staff, suppliers, and customers
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
* www.planet-pharma.com
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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