Talent.com
Quality Systems Specialist

Quality Systems Specialist

Integrated Resources Inc.Columbia Heights, MN, US
19 hours ago
Job type
  • Full-time
Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas : Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Title : Quality Systems Specialist

Location : Columbia Heights, MN

Duration : 12+months (Possibility of extension)

POSITION DESCRIPTION :

  • This position has primary responsibility for supporting and providing oversight of the Neuromodulation Quality Management System.
  • This position is responsible for ensuring the existing system is implemented and followed and will also be instrumental in improving the quality system as applicable.
  • This role will lead quality system projects, audit readiness activities, improvements or initiatives and collaborate with site manufacturing and operations teams.

POSITION RESPONSIBILITIES :

  • Ensure the Neuromodulation quality system is implemented, followed and the site maintains adherence to all quality policies, processes and procedures.
  • Evaluate, develop, update and maintain quality policies and procedures in accordance with industry standards and regulations, with Healthcare Corporate policies and best practices.
  • Provide quality expertise and guidance to the site personnel on quality system policies and procedures.
  • Coach site staff to ensure a thorough understanding and effective implementation of quality policies and procedures.
  • Serves as a liaison between Neuromodulation and various auditing agencies.
  • Works directly with operations personnel to ensure compliance to specifications and requirements.
  • Performs self-audits and will develop action plans for improving compliance from the self-audit results.
  • Perform audit readiness activities by evaluating documentation, records and ensuring personnel are audit ready.
  • Identify, lead or manage quality system improvements.
  • Improvements to focus on effectiveness, efficiency and when applicable drive simplification.
  • Provide support to the department and site as needed during audits and inspections.
  • BASIC QUALIFICATIONS :

    4-7 years of experience with a Bachelor's degree OR

    2-5 years of experience with a Master's degree

  • Previous Quality System or auditing experience
  • Previous medical device or other regulated industry experience
  • EDUCATION REQUIRED

    (No equivalencies)

  • Bachelor's degree in science or engineering
  • DESIRED / PREFERRED QUALIFICATIONS (optional) :

  • Experience in or support of manufacturing operations.
  • Change control documentation systems (e.g. Agile, Enovia or Documentum

    CAPA documentation systems experience (e.g. Trackwise)

  • Experience in both pharma and device product organizations.
  • Knowledge of all aspects of medical device operations (quality, manufacturing, supply change, design).
  • Bachelor's degree in science or engineering
  • ASQ certification as CQM, CQE, CQA

  • Experience revising and improving an existing quality management system
  • Working knowledge of Quality System Regulation (21CFR820), ISO 13485 : 2003, and CFR Parts 210 and 211.
  • Solid judgment and problem solving skills
  • Ability to manage multiple projects or priorities
  • Strong influence and negotiation skills
  • PHYSICAL JOB REQUIREMENTS

  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • Additional Information

    We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

    Thanks & Regards,

    Seema Chawhan

    Clinical Recruiter

    Integrated Resources , Inc.

    IT Life Sciences Allied Healthcare CRO

    Certified MBE GSA - Schedule 66 I GSA - Schedule 621I

    DIRECT # - 732-844-8724

    LinkedIn : https : / / in.linkedin.com / in / seemachawhan

    Gold Seal JCAHO Certified for Health Care Staffing

    "INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

    J-18808-Ljbffr

    Create a job alert for this search

    Quality Specialist • Columbia Heights, MN, US

    Related jobs
    • Promoted
    Quality Systems Manager

    Quality Systems Manager

    Cretex QTSMinneapolis, MN, US
    Full-time
    QTS is currently seeking an energetic, responsive and well-organized full time Quality Systems Manager.This position will be responsible for developing, implementing, and maintaining the quality ma...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Specialist

    Quality Specialist

    FreudenbergShakopee, MN, US
    Full-time
    Freudenberg Group Job Opportunity.Working at Freudenberg : We will wow your world!.Ensure Product Quality & Customer Satisfaction : Monitor and measure production outputs to meet or exceed customer e...Show moreLast updated: 18 days ago
    • Promoted
    • New!
    Site Project Manager

    Site Project Manager

    Anderson DahlenRamsey, MN, United States
    Full-time
    Grays Specialty Equipment segment offers a comprehensive range of expert services, including design, manufacturing, integration, installation, and maintenance of some of the most advanced systems i...Show moreLast updated: 20 hours ago
    • Promoted
    QA Specialist I

    QA Specialist I

    Pace Analytical Services, LLCOakdale, MN, United States
    Full-time
    Monday through Friday, 8 : 00 AM - 4 : 30 PM.Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward. to innovate and advance all aspects ...Show moreLast updated: 5 days ago
    • Promoted
    Quality Program Specialist

    Quality Program Specialist

    Allina HealthMinneapolis, MN, US
    Full-time
    Allina Health is a not-for-profit health system that cares for individuals, families, and communities throughout Minnesota and western Wisconsin. If you value putting patients first, consider a care...Show moreLast updated: 27 days ago
    • Promoted
    Sr Quality Systems Spec - Exempt

    Sr Quality Systems Spec - Exempt

    HireTalentSaint Paul, MN, US
    Full-time
    Job Description Spotlight Call with HM : 5 / 1 @ 4 : 45pm CST Dial-in by phone + • • • United States, Minneapolis Find a local number Phone conference ID : 488 497 807# Target BR : $ • • • • • • / hr Must Have : Min...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Documentation Specialist

    Quality Documentation Specialist

    Metal Craft | RiversideElk River, MN, United States
    Full-time
    The posted range reflects market-based pay.Actual compensation depends on experience, skills, and related qualifications. Elk River, MN is a precision machining company.Our company mission is to pro...Show moreLast updated: 3 days ago
    • Promoted
    • New!
    Quality Systems Specialist I

    Quality Systems Specialist I

    AgilitiEden Prairie, MN, US
    Full-time
    The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives. Participate in all Quality Management System (QMS) activities...Show moreLast updated: 19 hours ago
    • Promoted
    Workholding Technical Specialist

    Workholding Technical Specialist

    Mate Precision TechnologiesAnoka, Minnesota, United States, 55303
    Full-time
    Quick Apply
    Workholding Technical Specialist.Mate’s workholding solutions to successfully produce their products.This role combines technical expertise, CAD design, customer collaboration, and sales support to...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Project Manager

    Project Manager

    Anderson DahlenRamsey, MN, United States
    Full-time
    Grays Specialty Equipment segment offers a comprehensive range of expert services, including design, manufacturing, integration, installation, and maintenance of some of the most advanced systems i...Show moreLast updated: 22 hours ago
    • Promoted
    • New!
    Quality Systems, Contractor

    Quality Systems, Contractor

    Planet PharmaMinnetonka, MN, US
    Full-time
    Be among the first 25 applicants.Support administration of quality system events and GxP records maintenance.The Coordinator 2, Quality Systems will be responsible for assisting users in transition...Show moreLast updated: 19 hours ago
    • Promoted
    Quality Assurance Specialist- B Shift (6 : 00pm-6 : 00am)

    Quality Assurance Specialist- B Shift (6 : 00pm-6 : 00am)

    IWCOChanhassen, MN, United States
    Full-time
    Primary Duties / Responsibilities : .QC checks, verify QC pull compliance, and collect and file QC.Conduct process audits and provide training on new and existing process compliance as needed.Enter qua...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance Specialist- B Shift (6 : 00pm-6 : 00am)

    Quality Assurance Specialist- B Shift (6 : 00pm-6 : 00am)

    IWCO DirectChanhassen, MN, United States
    Full-time
    The Quality Assurance Specialist is responsible for assuring exceptional department processes and product quality.The Quality Assurance Specialist is responsible for providing training across the s...Show moreLast updated: 4 days ago
    • Promoted
    QA Specialist II

    QA Specialist II

    Pace Analytical Services, LLCOakdale, MN, United States
    Full-time
    Monday through Friday 8 : 30am to 5 : 00pm.Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward. to innovate and advance all aspects of...Show moreLast updated: 8 days ago
    • Promoted
    • New!
    Center Quality Manager I

    Center Quality Manager I

    Octapharma PlasmaBrooklyn Park, MN, US
    Full-time
    There are so many ways Octapharma Plasma can enhance your life and your career.Our strong growth is creating great learning and career development opportunities throughout our company, and especial...Show moreLast updated: 19 hours ago
    • Promoted
    Quality Assurance Specialist

    Quality Assurance Specialist

    Oxenham GroupSt Paul, MN, United States
    Full-time
    The Quality Process Analyst solves quality problems and is involved in quality improvement projects.This role can perform the document control processes, which includes making document changes, rou...Show moreLast updated: 5 days ago
    • Promoted
    Quality Assurance Specialist (St Paul)

    Quality Assurance Specialist (St Paul)

    Oxenham GroupSt Paul, MN, US
    Part-time
    The Quality Process Analyst solves quality problems and is involved in quality improvement projects.This role can perform the document control processes, which includes making document changes, rou...Show moreLast updated: 4 days ago
    • Promoted
    Quality Documentation Specialist

    Quality Documentation Specialist

    Metal Craft Machine & EngineeringElk River, MN, US
    Full-time
    The posted range reflects market-based pay.Actual compensation depends on experience, skills, and related qualifications. Elk River, MN is a precision machining company.Our company mission is to pro...Show moreLast updated: 2 days ago