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Quality Specialist II

Oakdale, MN 55128

Posted: 03/31/23 Industry: Other Job Number: 00006BB2 Pay Rate: 30.00

Job Description

Do you have an Associate Degree from an accredited college or university? Do you have Knowledge of the Medical Device Industry and FDA QSR regulations and Six-Sigma? Do you have 2-4 years of experience in a Quality role handling, communicating and reviewing customer complaint investigations, analyzing investigation data for trends and communicating trends to appropriate personnel within the organization? We are assisting our Oakdale, MN Client with their Quality Specialist II opportunity.

• The Quality Specialist II is responsible for handling, communicating and reviewing customer complaint investigations, analyzing investigation data for trends and communicating trends to appropriate personnel within the organization. Based on site may also be responsible for preparing complaint samples for investigation. May write and perform validations (process/test method) to introduce changes required for compliance to the QMS. May assist in engineering activities of intermediate scope to improve overall product quality and ensure local site compliance.

Essential Duties & Responsibilities
• 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
• Work on special projects as they arise
• Perform other related duties as assigned or required
• Support initiatives for continuous quality improvements
• 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

Knowledge & Skills
• 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
Minimum Qualifications, Education & Experience
• Must be at least 18 years of age
• Associate degree from an accredited college or university
• 2-4 years of experience

• Long Term Contract (10 Months)
• On-Site
• Oakdale, MN
• Full-time
• 1st Shift
• Monday - Friday
• 8:00 A.M. - 5:00 P.M.
• Pay: $30 - $33/hr.
• THE RIGHT STAFF offers healthcare, vacation, and referral bonuses

Applicants selected for this position with our client will be required to complete a background check & drug test. Successful completion of these assessments is required for further consideration.

Qualified candidates may apply by sending your Microsoft Word 2003 or higher resume to

We thank all interested candidates. However, only those selected for interviews will be contacted.
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