Manufacturing Quality Engineer

Location
Eagan, MN
Salary
Depending on Qualifications
Posted
Mar 03, 2017
Closes
Mar 24, 2017
Ref
143934
Job Type
Employee
Employment Status
Full Time
Doherty Career Solutions has partnered with a Medical Device startup company that is in need of a Quality/Manufacturing Engineer. The Quality/Manufacturing Engineer will work with the Operations and Quality departments to develop and maintain manufacturing processes and quality systems that meet the requirements of company's and external regulatory requirements, including ISO and FDA. This is a Contract to Hire opportunity with our partnering client.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Quality related:

  • Support the development and implementation of quality systems processes and related documents while insuring ISO and industry standard compliance
  • Evaluate measurement systems/processes, including: measurement system analysis, review/approval of processes, establishing and maintaining lot sampling plans, etc.
  • Supplier support, including: review/approval of validation reports, inspection plans, CAPAs
  • Analyze results of process capability studies and make recommendations
  • Participate with suppliers on quality and/or cost improvement initiatives
  • Working in conjunction with the Quality and Regulatory Manager to establish and maintain Quality Management System Manual, ensuring its content is aligned with regulatory requirements, business plan strategic objectives and customer expectations
  • Support validation and verification product testing
Manufacturing related:

  • Support and/or development of manufacturing processes, including: identifying and minimizing sources of variation, making recommendations on changes for quality and/or cost improvement, researching and proposing alternative methods
  • Overseeing supplier activities tied to manufacturing methods employed on company products
  • Develop Design of Experiments on manufacturing processes
  • Support the R&D of new products, up to and including the design transfer into manufacturing
Authority:

The Quality/Manufacturing Engineer is empowered with the authority to perform his/her assigned responsibilities and tasks as outlined in this job description and where documented in the Quality Management System policies and procedures.

REQUIRED/PREFERRED QUALIFICATIONS:

  • Experience in medical device manufacturing
  • Experience in manufacturing methods commonly employed in medical device manufacturing, including: injection molding, ultrasonic welding, thermoforming, heat staking, gluing, etc.
  • Familiar with ISO 13485 compliant quality systems and current Good Manufacturing Practices (cGMP)
  • Preferred experience in statistical process control (SPC)
  • Familiarity with Design History Files and Device Master Records
  • Experience in creating/executing process validation protocols and reports
  • General computer experience, including Word, Excel, etc.
  • Attention to detail and accustomed to producing high accurate work
  • Ability to work in a very fast paced environment with minimal supervision
  • Preferred four year engineering degree
  • Minimum 5 years' experience in a similar role within Manufacturing
CONTACT

To submit yourself for the Quality Manufacturing Engineer opportunity, please first apply online at www.doherty.jobs then call our Doherty Career Solutions office at 952-832-8390. You may also submit a resume directly to dss_careersolutions@doherty.jobs #EngineeringCareers

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