Hello,
My name is Shalini, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Quality Engineer I for a prominent client of ours. This position is located in ­­Irvine, CA
Title: Quality Engineer I
Location: Irvine, CA
Duration: 12 Months contract
Hourly Rate on W2: $28 - $39/hr

• The Quality Engineer is responsible for maintaining quality of post-market performance of medical devices.
• Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
• Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

• Bachelor's degree in Engineering or Natural Science
• 1-3 years of relevant experience in a regulated industry (FDA environment preferred)
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

About the Company:
The Fountain Group

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30 years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

Company Size:
500 to 999 employees

Industry:
Staffing/Employment Agencies

Founded:
0

Website:
https://www.thefountaingroup.com/