Quality Engineer - Onsite

Level of

Experience:

Mid - Level

Employment Type:
Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Work day/hours: 40 hours, M - F day shift

Position:
Quality Engineer

Location:
San Jose, CA

Duration: 6 Months

Total Hours/week: 40

1st Shift

Client:
Medical Devices Company

Job Category:
Engineering

• Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
• Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
• Conduct complaint investigations, assist in the investigation of manufacturing issues and provide data and input on technical issues and projects.

• BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred).
• Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.

• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software.
• Effective verbal and written communication skills.
• The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self‑motivated/directed, organized, detail oriented and have ability to multi‑task projects.
• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
• Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements.
• Ensure controls meet BD, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements.
• Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history.
• Provide quality support for Supplier Qualification and Approval steps and are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed.
• Support activities relating to Field Corrective Actions, when needed.
• Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.
• Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems.
• Experience in contracting manufacturer.

• B.S. or B.A. degree in an engineering or science field.
• Typically requires at least 3 years of experience in Quality / Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment.
• Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired.

• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820.
• Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.
• Strong background in Manufacturing processes including process development and optimization.
• Experience in managing variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses or Chemistry or Biological products.
• Proficient in project management, analytical, critical thinking, problem solving and prioritization skills.
• Demonstrate innovative and implementation skills.
• Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions.
• ISO 9001/13485 lead auditing experience.
• Strong Troubleshooting skills at both process and product level.
• Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise) is a plus.
• Lead Supplier Capability Assessments.