Job Description

Job Description: Sr. Quality Assurance (QA) Specialist

This exciting opportunity will support a differentiated business as it is established as a new independent medical device company, enableCV is a subsidiary of Edwards LifeSciences. EnableCV is based in Midvale, UT. This is a flexible on-site role which will thrive in a collaborative, start up like environment. We are a small tight-knit group of go getters that are willing to wear multiple hats, learn quickly, and be flexible in order to grow and develop this business. If you have the qualifications, want to work hard, and have a great time doing it, please apply.

Position Overview:

We are seeking a Sr. Quality Assurance (QA) Specialist to join our team. This role is critical in maintaining our quality management systems and ensuring compliance with industry standards. The ideal candidate will have a minimum of 5 years QA experience and possess strong administrative skills and familiarity with document control systems.

Requirements of the Sr. Quality Assurance Specialist:

• High school degree or higher
•  5+ years’ experience with quality procedures, standards, documentation, and quality assurance
• Excellent written and verbal communication skills
• Experience in a FDA regulated industry, medical device highly preferred

Key Responsibilities:

• Document Control: Manage and maintain document control systems, ensuring all documents are up-to-date and compliant with regulatory standards.
• Internal and Client Audits: Assist in preparing for and conducting internal and client audits, ensuring all quality standards are met.
• Training and Support: Provide training and support to team members on quality management systems and processes.
• Compliance: Ensure compliance with all relevant quality standards and regulations.
• Administrative Skills: Strong administrative skills with attention to detail and the ability to manage multiple tasks simultaneously.
• Communication: Excellent verbal and written communication skills, with the ability to work effectively with cross-functional teams.



Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, dedication, and people, we're the right company for you. We save lives every day and we love it - join us!

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