Description
The Client:The company has developed a patch to replace the halter monitor for early stage diagnosis and management of cardiac arrhythmia. The patch is a really simplified long-term monitoring solution that improves patient outcomes and greatly reduces cost. They have seen great success with their US commercialization and are now looking to gain CE mark to distribute internationally.
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