Implantica Group
Implantica is a global med-tech group dedicated to bringing advanced technology into the body and improving quality of life for patients around the world. Implantica’s lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin.
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 will provide you the opportunity to work in a multinational environment with the role 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 in which the business is commercial. 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 in which the business is commercial (includes 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.
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
• 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 with regards to supply chain activities.
• Project management skills as part of cross-functional development teams,
• Excellent working knowledge on FDA QSR requirements and ISO 13485.
• Good working knowledge on MDSAP requirements.
• Demonstrates strong attention to detail.
• Ability to work collaboratively across the organization with both internal and external teams and across different locations / time zones.
• Proficient with written and spoken English; strong written and verbal communication skills.
• Detail oriented and the ability to manage multiple activities simultaneously.
• Expertise in Microsoft Office applications and charting programs.
• Ability to travel internationally, as needed.
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