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Design Control Engineer

Sunnyvale, CA
Amick Brown is seeking an experienced Design Control Engineer for our direct client.
Location: Sunnyvale, CA
Duration: 5 Months.

  • Joining our clients means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position
  • The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems to maximize Patient Value.
  • This role will support managing and tracking of NCRs caused by suppliers, by using data analytics, and performance metrics to improve timely closures of NCRs.

Roles and Responsibilities
  • Supplier Quality and Performance Improvement
  • Drive NCR reduction and manage NCRs completion related to supplier caused issues, ensuring NCRs get assigned, approved, and closed in timely manner
  • Use data analytics to create NCR and performance metrics reports. E.g Pareto Charts
  • Drive meetings and follow up on closures of NCRs.
Investigate and resolve ISI Production line down events that are Supplier related; includes the following:
  • Initiation
  • Disposition non-conforming material (Containment)
  • Root Cause Analysis
  • Implement Corrective Actions/Preventive Actions
  • Documenting all of the above

Required Skills  
  • In order to adequately perform the responsibilities of this position the individual must possess:
  • BS degree in Engineering or equivalent
  • 2-7 years related experience in Manufacturing Engineering, Supplier Quality Engineering, or related field
  • Excellent written and verbal communication skills
  • Data Analytics, Metrics reporting,
  • Dependable Project Management skills
  • In-depth analytical and trouble-shooting skills
  • Experience with driving NCR improvements
  • Ability to read and interpret detailed specification drawings and communicate technical information
  • Advanced computer experience using Windows, MS Office Suite, SAP (or other ERP system), and Agile (or other document control system)

Preferred Skills
  • Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards)
  • Experience in a high-volume medical device company
  • We are an AA/EEO/Veterans/Disabled employer
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits:
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs
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