Director, Process Quality Engineering; Hybrid

Director, Process Quality Engineering (Hybrid)
Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada

Job Description
Posted Tuesday, December 23, 2025 at 11:00 a.m.

Your opportunity
By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.

Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – a revolutionary solution designed by our world-class technical team. The Globe System offers strong, unique, and customer-valued advantages over other treatments on the market, and leading physicians are already using it and helping to share our story.

We have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life‑changing technology to patients!

As a senior member of Kardium Inc.’s Quality Engineering team, and in close collaboration with Executive Management, the Director, Process Quality Engineering will be responsible for all strategic decisions and activities for enhancing Kardium Inc.’s Process Quality Engineering infrastructure to support our commercial production ramp up and expansions to other regions.

This role provides strategic leadership and governance over production controls, supplier quality, and the investigation of product quality issues, establishing a strong foundation for robust, compliant, and scalable manufacturing processes. The Director drives continuous improvement and risk‑reduction initiatives, partnering with Operations, R&D, Regulatory Affairs, and Supply Chain leadership to enable sustained manufacturing excellence and long‑term business performance.

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

Responsibilities

Define and lead the regional Process Quality Engineering strategy to ensure scalable, compliant, and capable manufacturing processes aligned with business growth and medical device regulatory requirements.

Establish the regional Process Quality Engineering organizational model, capabilities, and infrastructure to support current and future manufacturing needs, providing leadership and development for Process Quality Engineering Managers and their teams.

Develop and own a multi‑year process quality roadmap focused on reducing variability, strengthening process capability, and enabling operational excellence.

Serve as a strategic quality partner to Operations and R&D leadership, influencing manufacturing and design decisions to improve yield, reduce defects, and enhance long‑term process robustness.

Define, standardize, and govern Process Quality Engineering metrics and KPIs to drive enterprise‑level visibility, accountability, and continuous improvement.

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 will be successful in this role because you possess these attributes:

Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, or related disciplines) or a closely related technical field. Master's degree preferred

12–15+ years of progressive experience in quality engineering, manufacturing quality, or process engineering within the medical device industry.

5–8+ years of people leadership experience managing managers and cross‑functional teams within a multinational organization.

Demonstrated experience supporting high‑volume and/or complex manufacturing environments.

In‑depth knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and applicable global regulatory requirements.

Experience using quality management tools for process improvement and cost reduction

Advanced…