Manager, Commercial QA (Hybrid)

Kardium; Burnaby; Hybrid; CAD 110,000 - 120,000; Full time

Job summary

Kardium is seeking a Manager for their Commercial Quality Assurance team to lead the implementation of complaint handling systems in compliance with global regulations. This role requires extensive experience in the medical device field and necessitates collaboration with various departments to ensure the highest quality in complaint processing and management. The successful candidate will be pivotal in enhancing quality management systems while working in a hybrid environment.

Benefits

Comprehensive medical & dental coverage

Three personal days per year

Support for family building and maternity leave

Career progression and learning opportunities

Participation in stock option plan

Qualifications

• Minimum seven years of experience in the medical device industry.
• Two or more years in a managerial role.
• Strong working knowledge of ISO 13485 and FDA QSR.

Responsibilities

• Implement and maintain Kardium's Complaint Handling System.
• Oversee medical device complaint processing in compliance with regulations.
• Manage training for Kardium staff to report complaints in a timely fashion.

Skills

Strong analytical skills

Effective written & verbal communication

Team collaboration

Attention to detail

Education

Bachelor's degree in a technical/science field

Job description

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

We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.

Kardium has a unique opportunity for a Manager, Commercial QA. As a member of the Quality Assurance (QA) Team, the Manager, Commercial QA will be responsible for implementing, managing and improving Kardium's Complaint Handling System in accordance with applicable global regulations and requirements, including 21 CFR Part 820, ISO 13485 : 2016, Canadian Medical Devices Regulations, and EU MDR. This role will work in close collaboration with Customer Service and Field Service groups to process all customer issues and to identify customer complaints and will maintain all complaint and complaint investigation files according to Kardium's Quality Management System requirements. This person will work with stakeholder departments such as Engineering, Quality Engineering, Supply Chain, Clinical Affairs, Clinical Engineering and Regulatory Affairs on Post Market Surveillance strategy and execution. This role will also lead the CAPA Review Board and provide support to the maintenance of Kardium's Quality Management System (QMS). The position reports to the Director of Compliance and Quality Improvement.

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

What you'll be doing

Your responsibilities will include :

• Implement and Maintain Kardium's Complaint Handling System.
• Monitor Complaint handling system to identify process improvement to enhance surveillance and increase efficiency.
• Oversee medical device complaint processing at Kardium, in compliance with applicable regulations and standards, including FDA's Quality System Regulation (21 CFR Part 820), ISO 13485 : 2016, Canadian Medical Devices Regulations, and the European Medical Device Regulation.
• Ensure Kardium staff receive adequate training to identify and report complaints in a timely fashion.
• Manage the timely in-flow and triaging of customer complaints, assignment of investigation responsibilities, and expedient processing and closure of complaints to meet quality objectives. Ensure complaints are properly documented and evaluated for MDR and Vigilance Reporting.
• Establish and maintain Quality Data Metrics related to Complaints, CAPAs, and other QMS processes as assigned
• Analyze and interpret quality system performance metrics and prepare reports for PMS and Management Review
• Develop and provide leadership to the Commercial QA team
• Lead CAPA Review Board to facilitate processing and closure of open CAPAs, and review CAPA extensions and escalations
• Perform any other QA tasks as required, including but not limited to :

Leading root cause investigations and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts

• Conducting Internal Audits to assess the compliance of quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP
• Participating in external audits and regulatory inspections

What you bring to the team

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people's lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.

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

• Bachelor's degree, preferably in a technical / science field
• A minimum of seven years of experience in the medical device or related industry, with two or more years in a managerial role
• Strong working knowledge of ISO 13485 and FDA QSR
• Demonstrated knowledge and experience in CAPA
• Previous experience managing a complaint handling system
• Previous auditing experience and working knowledge of auditing techniques
• ISO 13485 Lead Auditor certification by a professional body is an asset
• Prior experience interacting with Regulatory and Notified Bodies during inspections
• Experience with electronic document and electronic record management systems
• Strong analytical skills and critical thinking
• Effective written & verbal communication and technical documentation skills
• Organized and detail-oriented
• Willingness to travel occasionally.
• Excellent interpersonal skills
• Ability to work effectively as part of a team and collaborate with staff at all levels
• Ability to influence and foster a culture of quality.
• Flexible and adaptable to take on additional responsibilities as appropriate

Compensation

Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

As a permanent employee, you will also participate in Kardium's stock option plan.

• 110,000 - $120,000 (CAD Annually)

The total cash we've listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.

Comprehensive medical & dental coverage for all permanent employees - effective as of Day 1, with no waiting period.

Work-day flexibility - additionally, we provide 3 personal days per year.

Support for you (and your dependents) overall well-being.

Family building - we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.

Career progression and learning support.

Professional membership support.

Life at Kardium

What makes us a great place to work?

Our Purpose

Our People

Our Culture

Brilliant

Achievers

Communication

Quality

Trust

Decision making

At Kardium, we embrace diversity of background, experience, and perspective and we're committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.

We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, and Irish ERG.

As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.

And our employees think we are great too - check out Glassdoor to learn more!

• Job Family LCA-Compliance

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