!*Quality Engineer - Leading contract manufacturing and medical device!*
!*Quality Engineer - Leading contract manufacturing and medical device!*
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!*Quality Engineer - Leading contract manufacturing and medical device!*
Location: Onsite close to Colchester
Job Description
Planet Pharma are working with a leading contract manufacturer specialising in medical devices, offering end-to-end services from design for manufacturing to full-scale production and packaging.
Join a fast-paced medical manufacturing environment where you’ll play a key role in maintaining product quality and regulatory excellence across the full lifecycle. Working alongside the Quality Manager and Regulatory Affairs Manager, your efforts will directly impact the safety, reliability, and compliance of life-saving medical technologies.
Key Responsibilities:
* Support the Customer driven Validation / Verification processes to ensure a successful and timely conclusion using the output from the process as the input into the in-process inspection criteria, sample size and frequency, etc.
* Support the Regulatory Affairs Manager to create and maintain product Technical Files in accordance with requirements.
* Maintain and improve the company's Quality Management System and internal processes.
* Lead targeted problem-solving activities to address specific problems as and when they arise during development and in production.
* Lead Change Management activities ensuring robust adherence to all processes and applicable requirements.
* Support adherence to the company’s Internal and Supplier Audit schedules and the implementation of robust actions to address and follow up on any issues raised.
* Act as an ambassador for Quality throughout all levels of the business. Help to ensure requirements are understood and participate in coaching and training activities as required.
* Other various quality-based tasks as directed by the Quality Manager.
Requirements:
* Knowledge of quality systems e.g., ISO9001, ISO13485, MDD/MDR, CFR Part 820 & ISO14971
* Experience of applying Quality Tools and Techniques within a relevant industry – e.g. FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, Statistical Analysis (Minitab).
* Excellent communication skills, both written and verbal.
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma
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 recognized 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.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing, Medical Practices, and Hospitals and Health Care
Referrals increase your chances of interviewing at Planet Pharma by 2x
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