Description
Impact this role will have within the organization:- Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.
- Investigates, and resolves system nonconformance's (defined during internal and/or external audits.
- Works with product development and production engineers during product development process to ensure quality deliverables (FMEA, Control Plans, and Risk Management) are in place prior to Design Transfer phase gate.
- Ensures compliance toIEC 6601, ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- As appropriate, utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
- Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
- As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member).
- As appropriate, participate in or lead in the completion and maintenance of risk analysis, as related to quality systems.
- Performs other duties as assigned.
Preferred Qualifications:
- Bachelors degree or higher in Engineering
- Prior medical device experience.
- Six Sigma certification.
- ASQ CQE, CQA certification.
To find out more about Real please visit www.realstaffing.com