QA Operations Manager US

Boston, Massachusetts, USA       ·       Full time

At ONWARD we’re looking for a QA Operations Manager US to join our team.

What you will do

The QA Operations Manager US warrants that the ONWARD Quality Management System is implemented and maintained within the US based team activities in accordance with ISO13485, QSR 21 CFR 820, and applicable regulations (MDR 2017/745). This person will ensure the ONWARD Quality Assurance activities are implemented on a risk-based approach, driving continuous improvement within the US team.

Responsibilities: 

• Establish and/or review quality procedures and other quality documents and records as per requirements of medical device governing standards and regulations (21 CFR Part 11, Part 820, ISO 13485, EU Medical Device Regulation) to ensure US team capability and compliance.
• Ensure proper application of applicable procedures in the US team activities.
• Support Onward US team in the drafting of their activities and processes as needed to align with EU headquarters processes.
• Manage, schedule, execute, and follow the internal audits process as appropriate.
• Support external audits/inspections.
• Manage the Document Control process as part of the Quality Management System.
• Promote continuous improvement within the US based team.
• Maintain, perform, and follow the Onward training system, coordinate document acknowledgement and training activities for the US based team.
• Maintain up to date Onward documentation for all US based team activities.
• Ensure corrective or preventive actions are taken to address quality related problems. (Complaints, device deficiencies. Nonconformities).
• Act as a local contact point for all activities related to post market phase for Onward devices (incoming, release, feedback, changes).

What we are looking for

• Master’s degree in life sciences or engineering
• 5 years with relevant industry experience in medical devices, preferably class III or AIMD
• Strong knowledge in ISO 13485, QSR 21CFR820, and EU MDR
• Experience with QMS changes to support a fast-growing organization in an international environment
• Experience as internal auditor
• Highly organized individual with strong organizational skills
• Strong drive to be precise and thrive for consistency
• Risk based analytical
• High integrity, quality focused
• Results oriented and hands-on individual who enjoys working in an international, cross-functional environment in a fast-paced and growing company
• Excellent communication and management skills, customer oriented
• Value quality
• Ethical person, with positive outlook and pragmatic attitude

Apply for the job

Do you want to join our team as our new QA Operations Manager US? Then we’d love to hear about you!

Apply now

OUR VISION

Empowered by movement, people with spinal cord injury will enjoy life in every way that matters to them. We are a team of scientists, engineers and physicians, collectively driven to create therapies that change lives. We understand the challenges of those living with spinal cord injury. Formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL), we are now headquartered at the High Tech Campus in Eindhoven, the Netherlands and within the city center in Lausanne, Switzerland. We also have a growing team based in Boston, Massachusetts, USA.

Please click here to apply.