Quality Engineer I in Cordova, TN at Volt

Date Posted: 6/27/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Cordova, TN
  • Duration:
    24 weeks
  • Date Posted:
    6/27/2018
  • Job ID:
    123432
  • Contact Name
    Volt Branch
  • Phone
    (901) 248-4022

Job Description

Volt is looking for a Quality Engineer for our client, a global leader in orthobiologics. 

Location: Memphis, TN

Job Purpose

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.

Software and Product Quality

  • Support software validation efforts including, but no limited to: evaluating software changes, test script review, validation documentation
  • Become proficient in validation efforts
  • Project and process planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met
  • Work with multiple project schedules and manage competing priorities
  • Support design transfer activities focused in development of inspection processes, GRR, capability studies and process/software validation
  • Facilitate Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development, including software development
  • Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams

Quality Systems

  • Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations
  • Provide guidance and investigation assistance to solve significant or chronic process, product or software problems. Discuss customer problems with Marketing and Sales as needed
  • Become proficient with SAP applications
  • Identify specification needs/requirements and assist with the creation/updates of specifications
  • Become proficient in root cause analysis techniques (e.g. fishbone diagrams, 5-Whys, process mapping, etc)

Adaptability

Maintaining effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusting effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful.

Collaborating

Working cooperatively with others to help a team or work group achieve its goals.

Continuous Improvement

Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas, and implementing solutions.

Managing Work

Effectively managing one’s time and resources to ensure that work is completed efficiently.

Technical/Professional Knowledge and Skills

Having achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise; leveraging expert knowledge to accomplish results.

Working through vision and values

Keeping the organization's vision and values at the forefront of daily actions.

Education

  • Bachelor’s degree in an Engineering or Science discipline or equivalent technical background, with emphasis in Quality or related fields preferred.

Knowledge/Skills

  • Data analysis and critical thinking skills
  • Ability to adapt and learn quickly
  • Good written and verbal communication; responsiveness
  • Ability to work well within a team and relate to all levels within the company
  • Conducts investigations and trains personnel on methods and statistical analysis tools. 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.
  • Understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA.

Experience

  • Minimum 2 years’ experience preferably working within the medical device industry and having the understanding of, and ability to interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820-
  • GD&T knowledge/experience (preferred).
  • Electronics background (preferred).
  • Software quality assurance experience (preferred).

Volt is an equal opportunity employer