Job description
We have a contract opportunity for a Quality Engineer in Irvine California. This position is approved for 1 year and could be extended. The client is a world class Medical Device manufacturer.Pay Rate: $33.00 to $36.00/Hr.
Summary:
Responsible for achieving cost-effective manufacturing of high-quality medical devices. Accountable for maintaining quality and control of manufacturing processes and post-market performance. Collaborating with internal and external stakeholders to achieve company objectives, contributing to technical root cause investigations, executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
Job Responsibilities and other work as assigned:
- Contributes to investigations into production and customer-facing quality issues of medium complexity to identify root cause, implement corrective and preventative actions, and monitor effectiveness. May execute tasks to support higher complexity investigations.
- Demonstrates understanding and application of role-specific technical and Quality skills.
- Develops cross-functional relationships to influence behavior within a team or project.?
- Monitors product performance using statistical analysis and risk-based approaches.
- Communicates technical problems and solutions within small teams and to direct manager.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
- Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing methods and equipment; conferring with equipment vendors.
- Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
- 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 pertaining to medical devices. Supports internal/external audits.
- Bachelor's Degree or Equivalent years of directly related experience.
- The ability to fluently read, write, understand, and communicate in English.
- 0 years of experience with a Bachelor’s degree in Engineering. (Or high school+8yrs; Assoc.+4yrs)
- Preferred 1-3 years of experience in Quality/Manufacturing/Operations/Engineering in Medical Device or Healthcare.
- Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, and SharePoint.
- Experience in project management, effective decision-making capabilities, strong analytical, problem solving and negotiation skills.
- Exposure to hands-on troubleshooting of complex electromechanical/optical machines/consoles.
- Experience working in MRP systems (i.e., SAP)
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.
Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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