1 day ago Be among the first 25 applicants
Direct message the job poster from Arevna
Head of Commercial @ Arevna | Delivering high performing teams in MedTech.
Purpose of the Role:
As a Quality Engineer, you will play a key role in supporting and enhancing the Quality and Regulatory functions within the business. This position is focused on ensuring that product development and manufacturing processes meet global regulatory and quality standards. You will work cross-functionally with design, marketing, and compliance teams to ensure robust quality documentation, regulatory submissions, and QMS compliance are consistently maintained.
Main Duties & Responsibilities:
* Provide quality and regulatory support to the design team to ensure documentation meets EU MDR, UK MDR, and ISO 13485 requirements.
* Lead and contribute to the creation and remediation of technical documentation, including authoring essential components of technical files.
* Support the development of regulatory strategy in collaboration with marketing, ensuring timely execution of global product registrations.
* Write, review, and improve procedures, templates, and forms that support the quality and regulatory functions.
* Assist in maintaining and improving the company’s Quality Management System in line with ISO 13485 and ISO 14971.
* Support CAPA investigations, internal audits, and implementation of corrective actions.
* Ensure labelling, Instructions for Use (IFU), and packaging meet global regulatory requirements.
* Stay current with global regulatory intelligence and support the business in maintaining compliance across all markets.
* Assist in quality activities related to product testing, verification, and validation, where appropriate.
Key Focus Areas:
* EU MDR & UK MDR Compliance
* Technical File Creation & Remediation
* Global Regulatory Submissions & Intelligence
* Labelling & Packaging Compliance
* ISO 13485 QMS Development & Maintenance
* CAPA Management & Internal Audit Support
* Risk Management and Usability Documentation (e.g. RMF, CER, PMCF)
Qualifications, Skills, and Experience:
* Solid understanding of EU MDR and UK MDR requirements.
* Proven experience in authoring or leading the development of technical documentation (e.g., Clinical Evaluation Reports, Risk Management Files, PMCF).
* Familiarity with labelling and packaging regulatory requirements.
* Experience with global product registrations and working with notified bodies or regulatory authorities.
* Knowledge of ISO 13485 and ISO 14971 standards.
* Strong communication and collaboration skills with internal teams and external partners.
This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.
Responsibilities
* Perform problem identification, resolution, loss reporting and continuous improvement
* Design and implement methods for process control, process improvement, testing and inspection
* Develop, execute, and analyze quality reporting measures
* Participate in internal and external quality audits
Qualifications
* Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
* 4+ years' of industry experience
* Strong knowledge of quality tools used in the industry
* Analytical and quantitative approach to problem solving
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Arevna by 2x
Sign in to set job alerts for “Quality Engineer” roles.
Sudbury, England, United Kingdom 10 hours ago
Colchester, England, United Kingdom 1 week ago
Suffolk, England, United Kingdom 2 hours ago
Process Engineering Expert (Sr. Principal Engineer)
Ipswich, England, United Kingdom 1 month ago
Clacton-On-Sea, England, United Kingdom 2 weeks ago
Ipswich, England, United Kingdom 15 hours ago
Colchester, England, United Kingdom 2 weeks ago
Leiston, England, United Kingdom 4 weeks ago
Colchester, England, United Kingdom 3 weeks ago
Stowmarket, England, United Kingdom 1 month ago
Elmstead Market, England, United Kingdom 4 months ago
Ipswich, England, United Kingdom 3 months ago
Ipswich, England, United Kingdom 4 days ago
Principal Software Engineer (in Ireland, visa sponsorship available)
Martlesham, England, United Kingdom 1 week ago
Tan Office, England, United Kingdom 4 days ago
Ipswich, England, United Kingdom 1 hour ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr