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Quality Assurance Specialist

2 months ago


Arden Hills, Minnesota, United States Integrated Resources Full time

Quality Assurance Specialist

Location: Arden Hills, MN

Contract Duration: 12 Months+

Work Schedule: 7:30/8am start time, 8-hour shifts, Monday to Friday.

Job Overview:

The role involves performing routine final functional assessments, ensuring compliance with product release criteria, and meticulously documenting test outcomes.

Key Responsibilities:

  1. Conducting systematic final functional assessments and inspections to validate product release criteria.
  2. Reviewing and revising Quality Assurance documentation as necessary.
  3. Compiling validation reports to ensure thorough documentation of processes.
  4. Executing product defect analysis to identify and rectify issues.
  5. Providing support and assistance to the Quality Engineering and Operations teams.
  6. Adhering to all Quality Assurance laboratory protocols and plant-wide procedures.
  7. Ensuring compliance with ISO9001 standards and current Good Manufacturing Practices (GMP).
  8. Delivering exceptional service to all internal stakeholders within the Quality Assurance laboratory.
  9. Reporting any concerns related to work processes that may impact environmental, health, or safety standards to management.
  10. Exercising decision-making capabilities while working independently with minimal supervision.
  11. Supporting laboratory safety initiatives and maintaining a 5S environment.

Quality Systems Responsibilities:

Commit to integrating quality into every aspect of work by upholding all quality requirements.

Qualifications:

  • Associate's Degree or equivalent experience in a relevant field.
  • Strong interpersonal and organizational skills.
  • Exceptional attention to detail.
  • Aptitude in:
    • Electronics
    • Mechanics
    • Physics, with a focus on fundamental testing principles
    • Computers (hardware and programming)
    • Experience with Bose Pulsing (Wintest software)
    • Hydraulics/Pneumatics or Fluid Dynamics
  • Proficiency in MS Excel and MS Word.
  • Mechanical assembly skills.
  • Technical writing capabilities.
  • Basic troubleshooting skills.
  • Ability to follow Standard Operating Procedures (SOP) and protocols.
  • Capability to lift up to 20 lbs when necessary.
  • Customer-oriented mindset.
  • Flexibility in scheduling.
  • Clear and effective communication skills.
  • Goal-oriented and self-motivated.
  • Ability to foster positive relationships and work collaboratively as part of a team.

Preferred:

Experience in a medical device laboratory setting is highly regarded.