Job Title: Quality Assurance Engineer

Reports to: Director of Quality

About CardiacBooster: CardiacBooster is a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of cardiogenic shock and acute heart failure. We are an enthusiastic team with diverse backgrounds and expertise, located in Galway, Ireland, and Nijmegen, Netherlands. CardiacBooster is an equal opportunity employer.

Job Description: A QA Engineer at CardiacBooster will be an experienced QA engineer with a strong knowledge of Quality system processes for medical devices with the aim of gaining ISO 13485 certification for CardiacBooster. You will work closely with Quality and Design Assurance counterparts, as well as R&D, Regulatory, Clinical, and marketing functions to support early product design and manufacturing scale-up. You will support the development of the quality system and ensure ongoing medical device quality control for the business.

Key responsibilities will include providing expertise on implementing and managing Quality System processes, Supplier processes and related activities as per applicable requirements, driving compliance and effectiveness. You will work closely with the team to problem-solve and proactively recommend solutions that improve the QMS, overall quality performance and compliance. You will ensure regular reporting of key performance metrics to the Quality Director. The successful candidate will have entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. The QA Engineer will be a team player and have excellent communication skills. This role will work from the company’s office in Ireland, and be in a position to travel occasionally.

  • Essential Job Responsibilities:
  • Implements, manages, and controls updates to Quality Management System documents while ensuring their accuracy, quality, and business agility.
  • Collaborates with cross-functional teams to support the development and approval of changes to the QMS.
  • Ensures company document changes meet procedural requirements and submits feedback to owners, as needed.
  • Supplier set up within QMS. Ensures that supplier quality documents are approved in a timely manner and follows up with process owners, as needed.
  • Provides Supplier Quality compliance guidance to team.
  • Support for 1st Article Inspection of material, Supplier assessment, incoming inspection, audits, and corrective action as required.
  • Provides metrics status to management for QMS and Supplier Quality related topics for Management review.
  • Supports external/internal Quality System and supplier audits.
  • Provide training on Quality best practices and QMS processes.
  • Supports regulatory submission documentation compilation and engages with external consultants to complete submission package.

Required Qualifications & Characteristics:

  • Qualification in quality or STEM discipline.
  • Previous experience in quality systems engineering, quality assurance, supplier quality or a similar role.
  • Experience using quality assurance software tools (eQMS) and processes.
  • Strong communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Experience of working effectively in team environments.

    Applications:

• Please submit your application, including resume, to hr@cardiacbooster.com

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel as classified.

categories: Quality
locations: Ireland

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