Current jobs related to Sr Quality Systems Specialist - Minneapolis - Three Point Solutions

  • Quality Systems Specialist

    1 week ago

    Minneapolis, Minnesota, United States Quality Tech Services, LLC Full time

    About QTSQuality Tech Services, LLC is a leading provider of critical end-of-line services for medical device OEMs. Our company offers finished device assembly, packaging, and sterilization management services. As part of the Cretex Medical family of companies, we are committed to delivering high-quality services that meet the needs of our customers.Job...

  • Senior Quality Systems Specialist

    3 weeks ago

    Minneapolis, Minnesota, United States Tactile Medical Full time

    Job Title: Senior Quality Systems SpecialistAt Tactile Medical, we are seeking a highly skilled Senior Quality Systems Specialist to join our team. This role is responsible for leading and maintaining quality system procedures and processes, ensuring product quality and safety in compliance with medical device regulations (ISO 13485, 21 CFR 820).Key...

  • Quality Engineer Sr.

    1 week ago

    Minneapolis, Minnesota, United States Detector Electronics LLC Full time

    Job Title: Sr. Manufacturing Quality EngineeringAt Spectrum Safety Solutions, we are seeking an experienced Quality Engineering professional to join our team. As a Sr. Manufacturing Quality Engineering, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Lead the development and implementation of quality...

  • Design Specialist Sr

    2 weeks ago

    Minneapolis, Minnesota, United States US Tech Solutions Full time

    Job DescriptionDuration: 6 months contract, Full-TimeEmployment Type: W-2Job Summary:We are seeking a highly skilled and experienced Design Specialist Sr to join our team at US Tech Solutions. The successful candidate will be responsible for creating innovative and practical mechanical and electro-mechanical concepts and designs for components, assemblies,...

  • Quality Systems Engineer

    2 days ago

    Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    About This RoleThe Quality Systems Engineer will play a critical role in ensuring the effectiveness of Inspire Medical Systems' Quality Management System. This position will specialize in training, providing leadership by educating employees on core quality principles, and driving a continuous learning environment. The successful candidate will have a strong...

  • Quality Systems Specialist

    4 weeks ago

    Minneapolis, Minnesota, United States Buhler Group Full time

    Job Title: Quality Systems TechnicianAt Buhler Group, we are seeking a highly skilled Quality Systems Technician to join our dedicated manufacturing team. As a Quality Systems Technician, you will play a crucial role in ensuring the quality of our products and processes.Key Responsibilities:Inspect incoming materials and verify critical dimensions and...

  • Quality Systems Specialist

    4 weeks ago

    Minneapolis, Minnesota, United States Buhler Group Full time

    Quality Systems TechnicianBuhler Group is a leading manufacturer of sustainable technology solutions, and we are seeking a highly skilled Quality Systems Technician to join our team.As a Quality Systems Technician, you will play a critical role in ensuring the quality of our products and processes. Your responsibilities will include:Inspecting incoming...

  • Sr Business Systems Analyst

    2 weeks ago

    Minneapolis, United States Liberty Diversified International Full time

    Description POSITION SUMMARY As a Sr. Business Analyst, you will support and improve the business applications used by the Liberty Diversified International (LDI) Packaging business. This position focuses on ERP solutions and other related business systems. Responsibilities include facilitating collaboration across our user base, working with teams to...

  • Information Security Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States Apex Systems Full time

    Sr Information Security EngineerApex Systems is a world-class IT services company seeking a highly skilled Sr Information Security Engineer to join our team.Key Responsibilities:Lead or participate in computer security incident response activities for moderately complex events.Conduct technical investigation of security-related incidents and post-incident...

  • Sr Design Specialist

    1 month ago

    Minneapolis, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a Sr Design Specialist to create and review mechanical and electro-mechanical designs, ensuring compliance with engineering standards and producibility constraints.Job Requirements:Proficient in tolerance analysis and Geometric Dimensioning and Tolerancing (GD&T)Comprehensive knowledge of military drawings,...

  • Quality Control Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States Actalent Full time

    Job Title: Quality Control SpecialistWe are seeking a highly skilled Quality Control Specialist to join our team at Actalent. As a Quality Control Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Conduct quality control tests and inspections to ensure compliance with...

  • Production Engineer

    2 weeks ago

    Minneapolis, Minnesota, United States Target Full time

    Job Title: Sr Production EngineerTarget is seeking a highly skilled Sr Production Engineer to join our team. As a Sr Production Engineer, you will be responsible for ensuring the quality and safety of our products, working closely with vendors and factories to drive continuous improvement and compliance with regulatory requirements.Key...

  • Sr. Merchandise Specialist | Dairy/ Frozen

    12 hours ago

    Minneapolis, United States Target Full time

    The pay range per hour is $19.62 - $35.29Pay is based on several factors which vary based on position. These include labor markets and in some instances may include education, work experience and certifications. In addition to your pay, Target cares about and invests in you as a team member, so that you can take care of yourself and your family. Target...

  • Regulatory Affairs Specialist

    3 days ago

    Minneapolis, Minnesota, United States Custom Search Full time

    At Custom Search, we are seeking a highly skilled Sr. International Regulatory Affairs Specialist to join our team. This key role will be responsible for ensuring the smooth registration and renewal of our products across international markets.The ideal candidate will have a strong background in regulatory affairs, with a minimum of 8 years of experience in...

  • Quality Control Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States ABR Employment Services Full time

    Job Title: Quality Control SpecialistWe are seeking a highly skilled Quality Control Specialist to join our team at ABR Employment Services. As a Quality Control Specialist, you will play a critical role in ensuring the quality of our products meets the highest standards of excellence.Job Summary:The Quality Control Specialist will be responsible for...

  • Mechanical Systems Specialist

    4 weeks ago

    Minneapolis, Minnesota, United States Horwitz Full time

    Job OverviewHorwitz is seeking a highly skilled and experienced Mechanical Systems Specialist to join our team. As a Mechanical Systems Specialist, you will be responsible for delivering Quality Assurance, Quality Control, and Commissioning services for our projects. This role ensures that project standards are maintained, and equipment/system installations...

  • Quality Assurance Specialist

    3 days ago

    Minneapolis, Minnesota, United States ELECTRIC MACHINERY COMPANY LLC, a division of WEG Full time

    Job OverviewELECTRIC MACHINERY COMPANY LLC, a division of WEG, seeks a Quality Assurance Specialist to support the Quality Team in ensuring products and processes comply with relevant requirements of Quality Management System and IS09001.The successful candidate will be responsible for maintaining and improving the Quality Management System, performing root...

  • Quality Assurance Specialist

    1 week ago

    Minneapolis, Minnesota, United States TE Connectivity Full time

    Quality Assurance SpecialistAt TE Connectivity, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This includes maintaining document control, process change management plans, and distributing hard copies. You will also be...

  • Sr. Accountant

    1 week ago

    Minneapolis, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are in search of a Sr. Accountant to be a part of our team located in Minneapolis, Minnesota. This role is in the Professional Services industry and calls for someone with a knack for both accounting and IT systems. As a Sr. Accountant, you will be tasked with handling a wide range of responsibilities, from processing...

  • Quality Assurance Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States PSG Global Solutions Careers Full time

    Job Title: Quality Assurance SpecialistAt PSG Global Solutions Careers, we're seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and reliability of our products and services.Responsibilities:Execute and participate in FMEA/Risk Management activitiesServe...

Sr Quality Systems Specialist

3 months 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

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