Quality Assurance Systems Expert

1 week ago

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

Position Title: Quality Systems Specialist
Client: Three Point Solutions
Contract Duration: 10 months
Work Schedule: 1st Shift - Flexible in-office and remote work 1-2 days per week

Essential Qualifications

Core Competencies:

  • CAPA Management
  • Learning Management Systems (LMS)
  • Quality Management Systems (QMS)
  • Training Development and Delivery

Preferred Skills:

  • QMS Optimization
Key Requirements
  • Experience in a regulated sector, ideally within medical devices or pharmaceuticals.
  • Proficient 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 Criteria
  • 3-5 years of relevant experience.
Primary Responsibilities
  • Oversee the creation and upkeep of quality programs, systems, processes, and procedures to ensure adherence to established policies and standards.
  • Provide expert guidance in interpreting compliance-related policies, regulations, and guidelines.
  • Collaborate with various entities to enforce compliance requirements.
  • Lead preparations for audits and inspections, address findings, and serve as a liaison with auditors and inspectors.
  • Coordinate responses to legal inquiries related to governmental investigations or litigation.
  • Maintain and enhance quality assurance programs and policies.
  • Facilitate the establishment of uniform standards globally and encourage the sharing of best practices.
Career Path
  • Individual contributor in a specialized field.
  • Manage projects from conception through to execution.
  • May mentor junior colleagues or guide entry-level professionals.
Autonomy and Impact
  • Operates independently with general oversight on complex initiatives.
Innovation and Complexity
  • Tasks are generally straightforward, requiring a broader understanding but typically 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 provide guidance to entry-level professionals or support staff.
Knowledge and Experience Requirements
  • Practical knowledge and demonstrated expertise typically gained through advanced education and relevant experience.
  • A University Degree and a minimum of 2 years of relevant experience, or an advanced degree with no prior experience is required.

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