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Quality Assurance Specialist

Reference ID: 161

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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 non-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. 

Take the next step and grow your career as our Quality Assurance (QA) Specialist. In this role, you provide direct QA support to our manufacturing and engineering teams and contribute to the effective operation of Kardium’s Quality Management System (QMS).

What you’ll do

  • Working collaboratively with our manufacturing team to conduct the QA review of production Device Master Record documentation, including work instructions and traveller templates, and reviewing production documentation to resolve any quality issues, including nonconformities, deviation permits and reworks
  • Executing the QA release of incoming and in-process goods
  • Conducting the QA review of Device History Records (DHRs) to support finished goods release
  • Root cause investigations (e.g., targeted DHR review)
  • Conducting the QA review of equipment documentation
  • Working closely with the engineering team to conduct the QA review of the verification & validation documentation, such as test protocols, test reports, investigation reports and engineering change requests
  • Conducting Managing the QA review of process validation and software tool documentation, such as test protocols and test reports.
  • Participating in the QA coordination of Change Control activities
  • Other QMS support such as contributing to Kardium’s Internal Audit program
  • Performing document control tasks such as documentation completeness verification and release of approved documents

What you bring to the team

Our Kardium team is smart, creative, and passionate about creating a cutting edge medical device 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 bring to the team these characteristics, plus:

  • At least three years’ quality assurance experience in a manufacturing environment, ideally in the biotech industry, where you have preferably gained experience in QMS planning and implementation.
  • Bachelor of Science degree in a technical discipline (e.g. Engineering, Physics, etc.)
  • An in-depth knowledge of ISO 13485, FDA QSR and QMS requirements of the European MDD
  • Hands-on experience with electronic document and electronic record management systems
  • Strong analytical skills and critical thinking developed through your education and working career
  • Well-developed written & verbal communication and technical documentation skills
  • The demonstrated ability to operate independently with minimal direction coupled with an organized and detail-oriented approach track and follow-up with the outstanding actions of your internal customers
  • Excellent interpersonal skills including the ability to resolve conflict with diplomacy and tact
  • The flexibility and adaptability to take on additional responsibilities as needed to achieve the team’s goals
  • Hands-on experience with educating internal customers on the internal QMS workflows and procedures

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide.
  • A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology.
  • An engaged leadership team who believes in mentoring and growing employees’ careers.
  • Supportive colleagues and plenty of fun social events to encourage employee interactions.
  • And our employees think we are great too – check out Glassdoor to learn more.

How to apply

Apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “161 QA Specialist” in the subject line. And if you are a recent grad, please include your GPA in your resume. 


Posted: March 4, 2019
Closes: April 10, 2019
Company Info
Size:
51-200 employees
Industry:
Technology

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About Kardium

Kardium® is developing a ground-breaking medical device, the Globe® mapping and ablation system, for the diagnosis and treatment of atrial fibrillation, one of the most common heart rhyth...