Highlights
Join a company dedicated to extending lives and transforming vital organ therapies. Collaborate on innovative projects and enjoy flexible working hours.
Description
Job Summary
pVantive is seeking a QA Engineer to join our dynamic team focused on advancing vital organ therapies. In this role, you will perform critical validation activities and ensure the highest standards of safety and quality in medical devices.
Responsibilities
- Execute V&V activities meeting safety, regulatory and quality requirements
- Develop fixtures for V&V activity under guidance of SMEs
- Maintain lab inventory for consumables
- Perform calibration and PM for test setups
- Understand protocols and adhere to QMS guidelines for testing
- Participate in lab audits to ensure compliance with site QMS
Required Skills
- Laboratory testing experience
- Knowledge of medical device regulations
- Fixture development skills
- Excellent communication skills
- Problem-solving abilities
Required Skills Explained
- Understanding of polymer science or mechanical engineering principles.
- Familiarity with test setups such as leak testers, torque testers, hardness testers, and drop testers.
- Aptitude for developing and maintaining lab fixtures required for validation activities.
- Proficiency in inventory management and maintenance of laboratory equipment.
- Experience with calibration and preventative maintenance (PM) procedures for testing equipment.
- Ability to comprehend and follow protocols, adhere to Vantive Quality Management System (QMS), and execute testing tasks accurately.
- Participation in lab audits conducted in compliance with the site’s QMS.
- Effective communication skills in English for both written and verbal interactions.
- Problem-solving abilities using root-cause analysis techniques.
Who is this for
pThis role is ideal for candidates with a background in polymer science, mechanical engineering or equivalent. You should have strong attention to detail and the ability to work effectively in a team environment.
Why This Job is a Good Opportunity
ulliOpportunity to work in an innovative company focused on extending lives through vital organ therapies.liPotential to contribute to meaningful innovations in kidney care and beyond, enhancing the dialysis experience for patients and care teams.liJoin a community of driven professionals who are committed to making a positive impact globally.liCompetitive benefits package and a supportive work environment that values individual growth and development.liDiverse projects allowing for a broad range of experiences and skill development within the lab setting.
Interview Preparation Tips
- Research Vantive’s mission, products, and recent innovations in vital organ therapies to demonstrate genuine interest during the interview.
- PRACTICE your communication skills, especially in English, as this is a mandatory requirement. Prepare examples of how you have effectively communicated technical information in the past.
- Prepare detailed examples of specific projects or tasks where you successfully developed and maintained lab fixtures, performed calibration procedures, or resolved complex issues using root-cause analysis techniques.
- Discuss your experience with test setups and inventory management, highlighting any relevant hands-on experience.
- Be prepared to explain how your problem-solving skills have helped you address challenges in a fast-paced environment.
Career Growth in This Role
pThe role offers significant growth opportunities as it allows professionals to advance their expertise in validation and quality assurance within the medical device industry. With experience, one can take on more complex projects and potentially move into leadership positions overseeing larger teams or specialized areas such as regulatory compliance or quality improvement.pVantive’s commitment to innovation and patient care provides a platform for career development that extends beyond technical skills to include soft skills like stakeholder management and effective communication. The company also encourages continuous learning, providing resources and opportunities for professional growth.
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Skills
Frequently Asked Questions
What qualifications are needed for this role?Candidates should hold a Diploma or Bachelor's degree in Polymer Science, Mechanical Engineering or equivalent with 1-3 years of experience.
Is medical device experience necessary?While not mandatory, prior exposure to the medical device industry is desirable but not required.
What kind of support can I expect from Vantive?Vantive provides comprehensive training and support for all team members to excel in their roles.
