Sr Quality Systems Specialist

3 weeks ago

Minneapolis, United States Three Point Solutions Full time
Job DescriptionJob Description

Job Title: Sr Quality Systems Specialist
Client: Medical Device Manufacturing Company
Duration: 7 months
Location: Minneapolis, Minnesota 55432
Shift: 1st Shift(20 hours per week is planned) (On site (our current requirement at Rice Creek is 3 days/week in office, so I think we'd want them to be on site for all their hours)

HM's Top Needs:

  1. (Strong Preference) Candidate has experience working in MAP Agile or Windchill.
  2. Candidate has excellent communication and interpersonal skills, working with Document Owners to execute change orders on revised documents.
  3. Excellent time management skills.

Client will be moving records from one electronic system to another, which will result in multiple Quality Management System procedural updates. This role's primary responsibility will be to work with document owners on redlines of changes and to create change orders in Agile MAP. The role will also work with document owners in individual or group meetings to ensure that required changes are made in time to meet the scheduled timeline.

Must Have (Minimum Requirements)

Responsibilities may include the following and other duties may be assigned:

  • Supports Quality System/Document Control activities including process and procedure changes and ensures that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with Subject Matter Experts, including Document Owners, to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

Education Required:
Bachelor's degree, preferably in science, engineering, or related fields.

Years' Experience Required:
4 years of Quality Management Systems and/or medical device experience.

Responsibilities may include the following and other duties may be assigned:

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
  • Coordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.

Specialist Career Stream:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors

  • Autonomy:
    Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
  • Organizational Impact:
    May be responsible for entire projects or processes within the job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity:
    Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence:
    Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
  • Leadership and Talent Management:
    May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work products.

Required Knowledge and Experience:

  • Requires advanced knowledge of the job area, combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management.
  • Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

#ZR

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