- Medical device experience
- Complaint handling experience preferred
- Product Risk Management experience/Post market quality experience preferred
- Collaborate with engineering and manufacturing teams to maintain quality standards.
- Ensure corrective actions align with reliability standards and compliant documentation.
- Specialize in design, material quality, production, and more related to product or process quality.
- Conduct comprehensive reviews and analyze HVAD system testing results to determine root causes.
- Generate detailed product investigation reports adhering to regulatory requirements.
- Engage in engineering projects to enhance analysis processes and reduce rework rates.
- Participate in validation tests for failure analysis equipment according to internal procedures.
- Autonomy: Entry-level contributor with supervision.
- Work Impact: Delivers work of limited scope, smaller projects, or related activities.
- Innovation and Complexity: Identifies and addresses issues, making necessary system changes.
- Communication: Engages with internal contacts to convey information.
- Leadership: Self-development focused role.
- Required Knowledge and Experience: Requires broad theoretical knowledge obtained through advanced education.
- Minimum Requirement: Baccalaureate degree.
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Quality Engineer - Hialeah, United States - Planet Pharma
Description
Top skills needed:
Education Required: Bachelor's/Master's in Biomedical/ Mechanical/Electrical Engineering
Years' Experience Required: 1-5
Work Environment: This exciting position allows for a hybrid work model, with 2 days remote and 3 days on-site.
In this engaging role as a Quality Engineer, you will be involved in developing, modifying, applying, and upholding quality standards and protocols for post-market analysis. You will conduct in-depth failure analysis of devices/components returned with reported malfunctions and work closely with various departments to ensure thorough product investigations. Additionally, you will lead discussions when new failure modes are identified.
Mechanical Circulatory Support Description
The Mechanical Circulatory Support Operating Unit oversees the company's heart pump program, specifically the HeartWare™ HVAD™ System. This system offers a left ventricular assist device (LVAD) that aids in pumping the heart and improving blood circulation within the body, featuring the world's smallest commercially available centrifugal flow pump.
Technical Specialist Career Stream: As a technical specialist, your role involves advancing existing technology or introducing new therapies. You will manage projects, collaborate with stakeholders, and may mentor colleagues.
Differentiating Factors:
