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Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company.
If interested please send me an updated resume.
Company: Global Medical Device
Title: Quality Engineer 1
Duration: 12-months to 7/28/2025 (Possibly to be extended)
Location: On-site in Irvine CA 92618
Must be local to Irvine CA 92618
No CTC, No Agency Partnership. No Sponsorship
Must Haves:
Bachelor's degree in Engineering, Biomedical, or related field
1-2 years of relevant experience in a regulated industry (FDA environment preferred)
New Grads are highly encouraged to apply
MS Office is needed
Preferred Experience:
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standards
Job Description:
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and 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.
Job Duties:
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.
Best Regards,
Alan Naroden - Senior Recruiter
Source One Technical Solutions - A WBENC Certified Company
Whitehouse, NJ
anaroden@source1tek.com
Cell: 908-385-3793
Contractor
Business Services
$95k-113k (estimate)
07/04/2024
08/01/2024
source1tek.com
SOMERVILLE, NJ
<25
1998
LINDA AKE
<$5M
Business Services
Source One Technical Solutions is a leading provider of professionals for consulting opportunities in the areas of Information Technology, Scientific and Engineering. We service clients in the Pharmaceutical, Telecommunications, Financial Services, Retail & Manufacturing, and Health Care industries. Our strength lies in our in-depth client analysis and employee selection process enabling us to accurately assess our employees skills and successfully match them to our clients needs. In addition, our senior-level recruiting staff is particularly adept at forecasting technology needs, strategizing..., and pipelining these individuals into our database. Once a partnership has been formed, the Source One recruiting staff will proactively maintain a network of qualified candidates, matching both the technical and interpersonal skills required by this particular client environment. This enables us to establish strong, lasting business relationships. Conceived with the client in mind, we offer a strong corporate support and value system with decentralized management principles. Our flexibility and entrepreneurial beliefs empower our local management teams to provide timely, cost effective and creative solutions to individual market and client demands. Source One Technical Solutions is a WBENC certified company.
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The job skills required for Quality Engineer 1 include Troubleshooting, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer 1. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer 1. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer 1 positions, which can be used as a reference in future career path planning. As a Quality Engineer 1, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer 1. You can explore the career advancement for a Quality Engineer 1 below and select your interested title to get hiring information.