Acumed
  • 12-Jun-2017 to 31-Jul-2018 (EST)
  • AcuVentures
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Time Off, Costco Membership Sponsorship, TriMet Pass, Summer Hours and more!


Job Summary!
Within the AcuVentures department of Acumed, The Quality Engineer 1 (QE1) is responsible for providing Quality Assurance support to product development and manufacturing to increase product quality, reliability, and process capability.  Participates on teams responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools.  Supports quality of new products being released to the market through participation in the product development process to ensure product and process conformance to global standards (including FDA and ISO 13485).

Duties/Responsibilities
 

  • Serves as a quality representative to design control, verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
  • Participates on teams to ensure robust application of appropriate design and manufacturing controls.
  • Supports projects teams on compliance to the quality standard including regulations, procedures, and requirements.
  • Supports senior engineers and leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
  • Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
  • Processes Quality Notifications (Non-Conforming Material Requests).
  • Creates and maintains final inspection plans.
  • Drives product risk management activities for assigned projects by using established processes to identify risk factors for use in decision making.  Drives identified risk mitigation activities and mitigation efforts to execution as agreed. 
  • Participates in technical discussions and risk-based decision making.
  • Reviews verification and validation reports and identifies gaps for compliance with Acumed polices and global regulations. 
  • Recommends strategies to close gaps in an efficient, technical, and compliant method. 
  • Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process. 
  • Applies basic theory and technical principles to address moderately complex problems. 
  • Regularly reports status updates on assigned responsivities and progress to assigned goals.  

Qualifications

  • Bachelor's degree in an engineering or science discipline
  • 1-3 years of experience working in quality assurance role, preferably in a regulated environment
  • Experience applying quality regulations and standards preferred (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
  • Knowledge of CAPA and failure investigation tools and techniques required, practical experience preferred.
  • Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DEO, trend analysis, etc.)
  • Ability to identify problems, review related information, develop and evaluate options, and implement solutions
  • Skilled oral and written communicator
  • Ability to work well in teams
  • Ability to be flexible in a dynamic work environment with shifting priorities
  • Intermediate level knowledge of Microsoft Office Suite of programs; advanced level Microsoft Excel skills preferred.

Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

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