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