Senior Quality Systems Analyst

2 weeks ago

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

Position Title: Senior Quality Systems Analyst
Client: Medical Device Manufacturing Organization
Duration: Contractual
Shift: Day Shift

Key Requirements:

  1. Preferred: Experience with MAP Agile or Windchill is highly desirable.
  2. Exceptional communication and interpersonal abilities to collaborate with Document Owners for executing change orders on updated documents.
  3. Strong organizational and time management capabilities.

The primary focus of this role involves transitioning records between electronic systems, necessitating various updates to the Quality Management System procedures. The individual will collaborate closely with document owners to review changes and generate change orders in Agile MAP. This position will also involve facilitating meetings with document owners to ensure timely implementation of necessary modifications.

Essential Qualifications:

Responsibilities may encompass the following and additional tasks:

  • Assists in Quality System and Document Control functions, ensuring that service performance and quality align with established internal and external standards.
  • Offers expertise in interpreting policies and regulatory requirements to ensure compliance.
  • Engages directly with Subject Matter Experts and Document Owners to oversee process analyses, enforcing compliance with regulations.

Educational Background:
Bachelor's degree in a relevant field such as science or engineering.

Experience Required:
Minimum of 4 years in Quality Management Systems or medical device sectors.

Additional Responsibilities may include:

  • Overseeing the development and upkeep of quality programs and procedures to ensure adherence to policies and standards.
  • Providing guidance in understanding regulatory and governmental policies to maintain compliance.
  • Collaborating with operational teams to continuously analyze processes and uphold regulatory requirements.
  • Leading preparation for audits and inspections, addressing findings, and liaising with auditors throughout the audit process.
  • Coordinating legal inquiries in support of investigations or litigation.
  • Ensuring the regular maintenance and updates of quality assurance programs and policies.
  • Facilitating global standardization and best practice sharing to support the company’s mission.

Career Path:
Typically an individual contributor with specialized responsibility. Manages assigned projects and collaborates with stakeholders to achieve objectives. May mentor colleagues or oversee the work of junior professionals. The role primarily involves delivering and supervising projects from conception to execution while adhering to established policies.

Key Differentiators:

  • Independence:
    A seasoned contributor who operates with minimal supervision, determining approaches to solutions and mentoring junior specialists.
  • Impact:
    May oversee entire projects or processes, contributing to the achievement of work group goals through relationship building and consensus.
  • Complexity:
    Challenges faced are multifaceted, requiring an understanding of various issues and specialties, leading to process enhancements.
  • Communication:
    Engages with senior internal and external stakeholders, sharing information to influence decision-making.
  • Leadership:
    May provide coaching and training to peers, managing projects that require delegation and oversight of work outputs.

Required Knowledge and Experience:

  • Advanced knowledge of the field, typically gained through higher education and relevant experience.
  • Practical understanding of project management may be beneficial.
  • A University Degree and a minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience is required.

#ZR

Company Overview

Three Point Solution is a premier firm specializing in contract, contract-to-hire, and professional placement services. We recognize the significance of aligning our clients with the right talent at the right moment. Our commitment to exceptional service benefits our clients, candidates, and employees alike. Unlike larger recruiting firms, we prioritize personalized attention, effectively bridging the communication gap between recruiters, employers, and candidates. Our objective is to foster and maintain genuine partnerships with our clients and candidates.

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