Quality Engineer in Durham, NC at Volt

Date Posted: 6/22/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Durham, NC
  • Duration:
    48 weeks
  • Date Posted:
    6/22/2019
  • Job ID:
    179501
  • Pay Rate
    $31.0 - $36.0/Hour
  • Contact Name
    Volt Branch
  • Phone
    919/829-1660

Job Description

Volt Workforce Solutions offers full-service staffing and talent management consulting to help local, regional, national, and international companies. Through niche recruiting expertise and project management, VWS delivers solutions in IT, Technology, Engineering, Accounting, Administrative, Call Center, Human Resources, Technical and Creative Communication, and Manufacturing.

Volt is an equal opportunity employer.

We are actively seeking a Quality Engineer for our client in Durham, NC. This is a great opportunity to work with a dynamic company that is a global leader in orthobiologics.

The Quality Engineer provides Quality Engineering support to Manufacturing, Engineering, QC/QA, and Process Development and IT teams to ensure that products are manufactured with a high level of quality, while being in compliance with regulations governing medical device manufacturing.

RESPONSIBILITIES INCLUDE:

  • Support Quality Systems such as delivery holds, lot release, internal and external audits, CAPA and investigations;
  • Conducts investigations and trains personnel on methods and statistical analysis tools;
  • Provide guidance and help solve significant or chronic process, product or software problems. Discuss customer problems with Marketing and Sales as needed;
  • Utilize SAP applications that track internal and external failures;
  • Identify specification needs/requirements and assist with the creation/updates of specifications
  • Perform root cause analysis using techniques such as fishbone diagrams, 5-Whys, process mapping, etc.

QUALIFICATIONS:

  • Bachelor’s degree in an Engineering or Science discipline or equivalent technical background, with emphasis in Quality or related fields preferred;
  • Must have 1 to 3 years of experience working within the medical device industry and have the understanding of, and ability to interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820;
  • Data analysis and critical thinking skills;
  • Good written and verbal communication; 
  • Ability to work well within a team and relate to all levels within the company;
  • Experienced in the use of quality tools such as Failure Modes Effects Analysis (FMEA), Fish Bone Diagram, Risk Analysis, or other appropriate methods to define and manage risk or identify root cause of failure;
  • Understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC);
  • Strong working knowledge of process development and Validation; methodologies (IQ,OQ,PQ) for process and software applications;
  • Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations.