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Quality Assurance Systems Analyst

2 months ago

Minneapolis, Minnesota, United States Three Point Solutions Full time
Job Overview

Position Title: Quality Systems Specialist
Client: Three Point Solutions
Duration: Contractual Engagement
Work Arrangement: Hybrid (Flexibility for remote work)

Essential Qualifications

Mandatory Skills:

  • Corrective and Preventive Action (CAPA)
  • Learning Management Systems (LMS)
  • Quality Management Systems (QMS)
  • Experience in Training and Development

Preferred Skills:

  • Experience in QMS Optimization
Key Requirements
  • Background in regulated sectors, particularly in medical devices or pharmaceuticals
  • Proficiency in managing QMS documentation and LMS
  • Adept at handling multiple projects simultaneously
  • Support for QMS documentation, LMS, training frameworks, and document control
  • Strong customer service orientation and meticulous attention to detail
Educational Background
  • Bachelor's Degree in a relevant field
Experience
  • 3-5 years of relevant professional experience
Primary Responsibilities
  • Oversee the creation and upkeep of quality programs, systems, processes, and procedures to ensure adherence to established policies and standards.
  • Provide guidance in interpreting regulations and compliance guidelines.
  • Collaborate with various entities to enforce compliance requirements.
  • Lead preparations for audits and inspections, address findings, and communicate with auditors.
  • Coordinate responses to legal inquiries related to investigations or litigation.
  • Maintain and adjust quality assurance programs and policies as necessary.
  • Facilitate the establishment of uniform standards globally and encourage the sharing of best practices.
Career Path
  • Individual contributor within a specialized field.
  • Manage projects from conceptualization to execution.
  • May provide mentorship to junior colleagues.
Autonomy and Impact
  • Operates independently with general oversight on intricate projects.
Innovation and Complexity
  • Typically addresses straightforward problems, requiring broader comprehension but generally not complex.
  • Recommends improvements to systems and processes.
Communication and Influence
  • Mainly interacts with internal stakeholders.
  • Engages in less complex external communications.
Leadership and Talent Development
  • May guide entry-level professionals or support staff.
Knowledge and Experience Requirements
  • Practical knowledge and demonstrated expertise typically acquired through advanced education and experience.
  • Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with no prior experience.