Quality Assurance Specialist

3 weeks ago

Minneapolis, Minnesota, United States PSG Global Solutions Careers Full time

Job Summary

We are seeking a skilled Quality Assurance Specialist to join our team at PSG Global Solutions Careers. As a Quality Assurance Specialist, you will be responsible for executing and participating in FMEA/Risk Management activities, serving as a technical resource for problem investigations, and working in a cross-functional, collaborative environment.

Responsibilities:

  • Executes and participates in FMEA/Risk Management activities.
  • Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
  • Works in a cross-functional, collaborative, team-based environment.
  • Works under minimal supervision, independently determining and developing approaches to solutions.
  • Contributes to the completion of specific programs and projects.
  • Anticipates roadblocks and provides direction for navigating the quality system and supporting applications.

Requirements:

  • Bachelor's degree in Engineering or technical discipline.
  • 2+ years quality, reliability, or design assurance engineering experience.
  • Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing.
  • Experience executing risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis.
  • Knowledge of applicable ISO standards and FDA regulations.
  • GMP, QSR, ISO 13485, ISO 14971 experience.
  • Ability to effectively manage multiple competing priorities.
  • Strong written and verbal communication skills.
  • Good interpersonal and group leadership skills.
  • Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.).

Desired Qualifications:

  • Master's degree.
  • 5+ years medical device or other regulated industry experience.
  • Experience with medical devices, in particular cardiac surgery devices.
  • Experience with reliability testing and analysis of medical devices.
  • Understanding of clinical/technical applications of cardiovascular products and human anatomy.
  • Certified Quality Engineer (CQE).
  • Certified Reliability Engineer (CRE).
  • Experience with ISO 5840, IEC 62366.
  • Effective negotiation, collaboration, and influencing skills.

About PSG Global Solutions Careers

Our client is an award-winning clinical development company, improving lives globally with 20+ years of experience in clinical research and strategic resourcing. We elevate results with proven strategies, comprehensive solutions, and customized delivery models. Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations, we provide strong relationships, connections, and access to great opportunities, along with industry expertise, career coaching, and professional training.

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