Manufacturing Quality Engineer

Company : TalentBurst, Inc.

Country: United States

Location : Irvine, California

Post: Thu, 16 Mar 2023 06:30:52 GMT

Expires: Thu, 13 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position: Manufacturing Quality Engineer , Req#: 765-1

Location: Irvine, CA (100% onsite)

Duration: 12 + Months Contract

Job Description:

Careers that Change Lives

A career at the client is like no other. We are innovative. We are impactful. We are the largest eye care medical device company helping restore sight and allowing millions of people worldwide to see brilliantly. We have a long history of industry firsts and a diverse highly talented team that keeps us on the cutting edge.

A Day in the Life

As a Quality Engineer supporting Manufacturing, you are responsible for achieving timely and cost-effective manufacturing of high-quality medical devices. The Quality Engineer is accountable for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Key duties include collaborating with internal and external stakeholders to achieve company objectives, contributing to technical root cause investigations, executing risk-based decisions, resolving and documenting customer complaints and manufacturing investigations, and representing Quality in cross-functional projects.

Education and Experience:

Bachelor’s Degree or Equivalent years of directly related experience (or high school+8yrs; Assoc.+4yrs)

The ability to fluently read, write, understand, and communicate in English.

0-1 year of relevant industry experience

Preferred Qualifications/Skills/Experience

Preferred 1-3 years of experience in Quality/Manufacturing/Operations/Engineering in Medical Devices or Healthcare.

Excellent verbal/written communication skills

Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, and Sharepoint.

Experience in leadership, project management, effective decision-making capabilities, and 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)

Key Responsibilities:

Contributes to investigations into production and customer-facing quality issues of medium complexity to identify root causes, implement corrective and preventative actions, and monitor effectiveness. May execute tasks to support higher complexity investigations.

Demonstrates conceptual understanding and application of role-specific technical and Quality skills

Develops cross-functional relationships to successfully influence behavior within a team or project.

Monitors global product performance using data-driven statistical analysis and risk-based approaches.

Effectively communicates (written and verbal) technical problems and solutions within small teams and to the direct manager.

Performs hands-on troubleshooting of customer-returned devices and manufacturing nonconformities and completes associated technical documentation.

Develops and improves manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing 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.