Description
The Client:The Client is the world leader in providing early stage diagnosis and management of cardiac arrhythmia information. They are aiming to simplify long-term monitoring solution to improve patient outcomes and reduce costs.
The Role:
The Quality Engineer III will provide technical engineering support of product life cycle, from concept through commercialization and post-market evaluation. Will also help establish and maintain Quality System compliance to all applicable regulatory requirements.
Responsibilities:
- Serves as a Quality Assurance representative on one or more project teams engaged in new product development, quality processes improvements, business system implementations or other special projects
- Knowledge in Quality Systems to execute overall project assignments
- Apply statistical tools to analyze data and identify root cause and problem resolution
- Identify and routinely use the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Review and approve product documentation, drawings, process and design verification/validation
- Serve as technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
- Perform and lead risk assessment exercises in support of validation activities
- Plans, develops, implements, and maintains the document change control system.
- Consider the application of privacy, security, environmental, health and safety standards.
- Assist and participate in internal and external audits, including supplier audits.
- Produce technical reports to support product changes or quality assurance investigations.
Required Qualifications:
- B.S in Engineering or relevant science.
- 7-10 years of experience in Quality Assurance
- 21 CFR 820, MDD/CMDR, ISO13485, ISO 14971, IEC 60601, HIPAA
- Exceptional problem-solving skills.
- Exceptional organizational skills.
- 20% Travel
- Experience with ERP/MRP systems