Erp Qa Business Analyst

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

We are looking for a skilled Quality Assurance (QA) ERP Business Analyst to join our team. The ideal candidate will have a strong background in quality management systems for the manufacture and distribution of complex medical devices and experience with ERP systems, such as SAP and Microsoft Dynamics. In this role, you will work closely with the QA, Manufacturing and Supply Chain teams and other stakeholders to analyze business processes and requirements and design efficient and compliant solutions. You will also be responsible for configuring and testing the ERP system to ensure that it meets the organization's needs and requirements.

Please note, this opportunity is an on-site work arrangement, located in Burnaby, BC.

What You’ll Be Doing

Key responsibilities will include:

• Stay up to date with industry trends and best practices related to QA, Regulatory and ERP systems.
• Work with technical teams to translate business requirements into technical specifications.
• Analyze current business processes and identify areas for improvement, including automation opportunities and efficiency gains.
• Collaborate with stakeholders to understand their business requirements related to Quality Assurance (QA) for the Engineering, Manufacturing, QA, Quality Control, Quality Engineering, Regulatory Affairs (RA) and Supply Chain teams.
• Monitor system performance and help identify opportunities for continuous improvement.
• Design and execute test plans to ensure the robustness, efficiency, and usability of new or enhanced systems and processes.
• Create training materials and conduct training sessions for end-users and stakeholders on new or enhanced systems and processes.
• Define business requirements related to QA for the ERP system, including functional specifications, system workflows, and use cases, that are compliant with the QMS and applicable regulatory requirements.

What You Bring To The Team

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.

You are suited to our approach and possess these qualifications:

• At least 3 years’ QA experience in a manufacturing environment in the biotechnology industry; experience in QMS planning and implementation an asset
• Knowledge of project management methodologies, such as Agile and Waterfall
• Experience with tier 1 ERP systems such as Microsoft Dynamics and SAP
• Thorough knowledge of documentation and record control systems; experience with electronic document and electronic record management systems an asset
• Excellent communication and collaboration skills and ability to drive consensus decisions across multi-functional user groups
• Strong, in-depth, working knowledge of ISO 13485, FDA QSR and QMS requirements of the European MDR; organizational awareness of quality management system implementation and operations
• Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.)
• Strong understanding of operations processes covering planning, purchasing, manufacturing, inventory control, and distribution/logistics

Why work at Kardium

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

• A great working environment with opportunities to develop your skills and knowledge
• An engaged leadership team who believes in mentoring and growing employees’ careers
• And our employees think we are great too – check out Glassdoor to learn more!
• Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
• Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
• Supportive and fun colleagues with plenty of social events to encourage people connections

Thanks in advance for your interest in Kardium!