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Quality Specialist - Immediate Opening 

Oakdale, MN 55128

Posted: 02/28/2023 Employment Type: Contract To Hire Category: Engineering Job Number: 64939 Pay Rate: 33.00

Job Description

Quality Specialist - Immediate Opening 

Leading medical devices company wants to add a Quality Specialist to their growing team in Oakdale, MN.  This is a temp to hire opportunity. 

Responsibilities of the Quality Specialist:
  • Analyze product failures for root cause.
  • Review product complaint investigations for completeness and accuracy.
  • Perform customer complaints analysis for unreturned serialized devices.
  • Maintain documentation and records resulting from quality management system activities and according to established procedures.
  • Provide inputs to the Global Service Quality Management Review and monthly Operational Review meetings.
  • Utilize technical background (including statistical knowledge and root cause analysis tools) to assist in data collection, analysis and reporting associated to process improvement but also as input to management for decision making.
  • Actively participates in preventive/proactive quality and operations improvement projects.
  • Ensure fulfillment of compliance training requirements per established schedule.
  • Conducts independent analysis and develops solutions to problems.
  • Receives general project direction. Solicits input from more experienced technicians and engineers.
  • Interface with departments such as R&D, Manufacturing Engineering, Supplier Engineering, Customer Service, Service and Repair to resolve product related issues and in general maintain device compliance
  • Develop a broad understanding from start to end of the post market surveillance process in the company.
  • Participate in review of design assessments, active participation in design reviews and risk management processes.
  • Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
  • Initiate and/or Provide support for Quality System procedure changes.

Qualifications of the Quality Specialist:
  • Must be at least 18 years of age.
  • Associate degree from an accredited college or university.
  • 2-4 years’ experience.
  • Knowledge of the Medical Device Industry and FDA QSR regulations.
  • General understanding of automation, medical-device assembly, controls, etc.
  • Introductory statistical analysis skills Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.).
  • Technical writing competency.
  • Competent in your domain. Familiar with other areas of domain expertise within the team.
  • Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline.
  • Ability to receive general project direction and solicit input from more experienced technicians and engineers.

Quality Specialists apply today!
  DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 
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As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.