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Assoc Quality Engineer
Ref No.: 18-50099
Location: Jacksonville, Florida
Start Date / End Date: 09/24/2018 to 12/31/2019
Company: Artech Information Systems
Job Title: Assoc Quality Engineer
Location: Jacksonville, FL
Duration: 15+ months
Job Id: - 18-50099
 
POSITION DESCRIPTION:
This position has the responsibility and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Participate in Risk Management Process. Coordinate feedback of quality indicators and statistics to business team for use in business decisions.  Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations.  QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards.  Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams. Position has multiple task responsibilities assigned per business need. High volume of quality documentation must be created by this position.
 
POSITION RESPONSIBILITIES:
  • Participates in Business Team operations to approve testing of all new product designs, design test parameters for R&D, Operations and QA, conduct reliability assessments,
  • Evaluates and approves ECN changes for existing products, monitor design developments for maintaining quality compliance and assists in software engineering, testing, and validation.
  • Partners with Mfg. Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
  • Participates in new product development, and establishes quality and reliability expectancy of the finished product.
  • Identifies, applies, and updates engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling.
  • Investigates and reports on corrective actions effectiveness and timeliness.  Assists audits of finished products, final inspections, returned and serviced products.
  • Establishes and conducts a Failure Analysis Process to ensure Field Returns and Internal Product Failures are investigated to determine the root cause of the product deficiency.
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • All other duties as assigned.
  • Travel requirement: Less than 10%
 
BASIC QUALIFICATIONS:
EDUCATION REQUIRED: 
  • Bachelor’s degree in Engineering required.
 
YEARS OF EXPERIENCE 
  • 2+ year’s experience with a Bachelor’s degree in engineering or 1+ years with a Masters degree in engineering.
  • 2+ years Quality Engineering or equivalent experience.
  • Minimum of two years industry experience, preferably in the medical device manufacturing industry.
 
SPECIALIZED KNOWLEDGE REQUIRED       
Medical Device previous experience
 
PREFERRED QUALIFICATIONS 
  • Experience in medical device design and application of test standards.
  • Good oral and written communication skills. Bilingual (Spanish language) not a requirement but is a high desirable plus.
  • Mechanical, Industrial, Biomedical or Electrical Engineering Degree preferred.
  • Knowledge in Validations (IQ, OQ, PQ protocol and reports)
  • Knowledge in Statistics techniques (DOE, SPC, sampling plan, …)
  • Knowledge in SAP. Not a requirement but is a plus.
  • Knowledge in AGILE. Not a requirement but is a plus.
  • Strong Quality documentation skills
  • Ability to provide solutions to a wide variety of technical problems of moderate scope and complexity.
  • Ability to work under general supervision.
  • Cross-functionally and effective team player.
  • Excellent presentation skills.
  • Must be able to handle multiple tasks/projects and manage priorities accordingly.
  • Working knowledge of appropriate industry standards.
  • Experience in application statistical methods to design reliability and process capability.
  • Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards.
  • Experience in application of statistical methods.
  • Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. If Bachelors or Masters degree is not in engineering an applicable professional certification is required.
  • Complete understanding and wide application of technical principles, theories, and concepts in the field.
  • General knowledge of other related disciplines.
  • Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
  • Good oral and written communication skills.
  • Cross-functionally and an effective team player.
  • Excellent presentation skills.
  • Must be able to handle multiple tasks/projects and manage priorities accordingly.
  • Working knowledge of appropriate industry standards.
  • Experience in application statistical methods to design reliability and process capability.
  • Must be able to work in a team environment and exert influence without alienating others.
  • Working knowledge of statistical analysis/software experience preferred.
  • Proficiency in Microsoft Project.
 
Thanks
Rajiv Maruthi
Rajiv.maruthi@artech.com