Senior Software Quality Assurance EngineerImplantica • London, England, United Kingdom
Senior Software Quality Assurance Engineer
Implantica
- London, England, United Kingdom
- London, England, United Kingdom
Über
The Role:
We are seeking a Sr. Quality Assurance (QA) Software Engineer to validate and manage our electronic Quality System (eQMS) Modules/Processes and validate, implement and manage an ERP System. This position offers the opportunity to work in a multinational environment with remote‑based work in the UK or EU.
Key Responsibilities & Tasks:
QMS Responsibilities
Develop, validate, implement, manage, and maintain electronic Quality System (eQMS) Modules/Processes that are compliant with regulatory requirements in applicable regions.
Work with internal personnel to ensure that accurate information is fed into the system, maintained, and linked to downstream processes.
Develop Quality Plans for the implementation of new processes, enhancements, or continuous improvements to existing processes.
Prepare documentation, plan, schedule, and execute validation activities of the QMS software utilizing a risk‑based approach. Ensure compliance to medical device industry regulations, including 21 CFR Part 11, EU GMP Annex 11, and EU GDPR.
Supply Chain Responsibilities
Validate, implement, manage, and maintain an ERP System that is compliant with regulatory requirements in applicable regions, including management of inventory invoices.
Work with sub‑contractors and downstream distributors to ensure that accurate information is fed into the system, maintained, and linked to downstream processes.
Support Regulatory audits/inspections as a Subject Matter Expert (SME).
Your Profile :
Minimum 5 years of related experience in QMS Software Validation with a Bachelor’s degree, or 3 years of related experience with a Master’s degree.
Demonstrated experience in eQMS and/or ERP software validation/tasks.
Experience with US Class III devices and/or EU Class IIb devices strongly preferred.
Knowledge of manufacturing processes and international logistics.
Knowledge and experience with processes and ERP systems related to supply chain activities.
Project management skills as part of cross‑functional development teams.
Excellent working knowledge of FDA QSR requirements and ISO 13485.
Good working knowledge of MDSAP requirements.
Demonstrates strong attention to detail and the ability to manage multiple activities simultaneously.
Proficient with written and spoken English; strong written and verbal communication skills.
Expertise in Microsoft Office applications and charting programs.
Ability to travel internationally, as needed.
NOTE: A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline.
We offer you:
A challenging and exciting position in an open and dynamic company.
A motivated, dedicated and international team.
Modern working conditions with flexibility.
Interested? Please apply directly through LinkedIn. For more information, visit www.implantica.com
Seniority level
Associate
Employment type
Full‑time
Job function
Information Technology, Quality Assurance, and Project Management
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klicken Sie auf „Jetzt Bewerben“, um Ihre Bewerbung direkt auf deren Website einzureichen.