ERP QA Business Analyst

2 weeks ago

Burnaby, Canada Kardium Full time

**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 mínimally-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.

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

**What you'll be doing**

Key responsibilities will include:

- 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.
- Analyze current business processes and identify areas for improvement, including automation opportunities and efficiency gains.
- 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.
- 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.
- Work with technical teams to translate business requirements into technical specifications.
- Monitor system performance and help identify opportunities for continuous improvement.
- Stay up to date with industry trends and best practices related to QA, Regulatory and ERP systems.

**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:

- Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.)
- At least 3 years' QA experience in a manufacturing environment in the biotechnology industry; experience in QMS planning and implementation an asset
- 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
- 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 understanding of operations processes covering planning, purchasing, manufacturing, inventory control, and distribution/logistics
- Experience with tier 1 ERP systems such as Microsoft Dynamics and SAP
- Knowledge of project management methodologies, such as Agile and Waterfall

**Why work at Kardium**

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

- Knowing every day that you are making a difference in people's lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- 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
- An engaged leadership team who believes in mentoring and growing employees' careers
- Supportive and fun colleagues with plenty of social events to encourage people connections
- And our employees think we are great too - check out Glassdoor to learn more

Thanks in advance for your interest in Kardium

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