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Quality Systems Specialist

4 months ago


Brooklyn Center, United States Three Point Solutions Full time
Job DescriptionJob Description

Job Title: Quality Systems Specialist (Hybrid)

Client: Medical Device Manufacturing Company

Duration: 1-year contract with possible extension

Location: Brooklyn Center, MN, 55430

Shift: 1st Shift

Job Description:

Must Have:

  • CAPA
  • LMS
  • QMS
  • Training experience

Nice to Have:

  • QMS Simplification

HM's Top Needs:

  • Regulated industry experience (preferably medical device or pharma)
  • Experience managing Quality Management System documents and Learning Management Systems (Training)
  • Ability to manage multiple projects

Education Required:

  • Bachelor's degree

Years' Experience Required:

  • 3-5 years+

Responsibilities:

  • Oversee the development and maintenance of quality programs, systems, processes, and procedures ensuring compliance with policies and established standards.
  • Provide expertise in interpreting policies, regulatory and governmental regulations, and agency guidelines to ensure compliance.
  • Work with operating entities for process analyses to enforce requirements and meet guidelines.
  • Lead audit and inspection preparation, resolve findings, and liaise with auditing groups and inspectors.
  • Coordinate legal requests in support of government investigations or litigations.
  • Maintain and modify quality assurance programs and policies regularly.
  • Facilitate uniform standards worldwide and enable best practice sharing to support the company's global mission.

Specialist Career Stream:

  • Individual contributor with responsibility in a professional discipline.
  • Deliver/manage projects and work with stakeholders to achieve desired results.
  • May mentor colleagues or direct lower-level professionals.
  • Spend the majority of time overseeing projects from design to implementation.

Autonomy:

  • Work independently with general supervision on larger, moderately complex projects.

Organizational Impact:

  • Set objectives to meet project milestones and may be involved in cross-functional assignments.

Innovation and Complexity:

  • Solve general problems and make system/process adjustments to improve job effectiveness.

Communication and Influence:

  • Primarily communicate internally to share information, status, needs, and issues for decision-making support.

Leadership and Talent Management:

  • May guide entry-level professionals and/or support stream employees.

Required Knowledge and Experience:

  • Practical knowledge and competence typically obtained through advanced education and experience.
  • University degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
#ZRCompany DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.