Quality Assurance Specialist II

1 week ago

Round Lake, Illinois, United States Experis Full time
Position Overview:

Our client, a leader in the Medical Device sector, is in search of a Quality Assurance Specialist to enhance their operational team. This role is crucial within the Medical Device division, ensuring compliance and quality standards are met effectively. The ideal candidate will possess 1-3 years of relevant experience in the medical device field, aligning with the organization's objectives.

Job Summary:

This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Specialist focusing on Complaint Investigations.

Key Responsibilities:
  • Take primary responsibility for the investigation, review, and resolution of all Quality Engineering complaint analysis tasks, utilizing various quality system inputs.
  • Examine individual complaints and related service data to assess risk levels and conduct thorough investigations into identified problem codes and causes.
  • Analyze data from diverse quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to identify trends and systemic issues, preparing comprehensive reports based on the analysis.
  • Review existing investigation reports to identify compliance gaps and develop strategies to address these efficiently.
  • Establish and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.
  • Drive corrective actions and continuous improvement initiatives that directly influence performance metrics through primary investigations and data analysis.
  • Lead corrective and preventive actions in manufacturing using formal problem-solving methodologies.
  • Support CAPA and maintenance activities for current product lines.
  • Recommend and assist in projects aimed at enhancing the quality system as approved by management.

Qualifications:
  • Experience in the Medical Device industry with a solid understanding of 21CFR820 preferred.
  • Strong investigational research skills.
  • Familiarity with statistical software packages (Minitab is a plus).
  • Experience in developing and implementing Quality Systems, process controls, and continuous improvement methods.
  • Knowledge of FDA cGMP, ANSI/ISO/ASQC requirements; CMDAS (optional).
  • Ability to read and interpret blueprints and technical drawings.
  • Proven analytical problem-solving skills (Root Cause Investigations).
  • Strong technical understanding of engineering principles and procedures.
  • Proficient in Microsoft Office Suite, Minitab, Access, and database management.
  • Ability to manage multiple projects methodically.

Education:
  • A Bachelor's degree in Engineering with 1-3 years of experience in the Medical Device sector.

Physical Requirements:
  • Able to exert up to 10 pounds of force occasionally.
  • Able to sit, stand, and walk throughout the workday.

If this opportunity aligns with your career goals, we encourage you to explore this position further. We look forward to discussing your potential fit for this role.

  • Quality Assurance Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Mindlance Full time

    POSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer II. KEY RESPONSIBILITIES:This role is primarily accountable for the investigation, evaluation, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality system inputs. Assess individual...

  • Quality Assurance Specialist

    5 days ago

    Round Lake, Illinois, United States Takeda Pharmaceutical Company Ltd Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda Pharmaceutical Company Ltd. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesResponsible for the receipt, release, and investigation of raw materials and bulk...

  • Quality Assurance Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Mindlance Full time

    POSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer, focusing on complaint investigations.KEY RESPONSIBILITIES:This role is primarily responsible for the thorough investigation, assessment, and resolution of all Quality Engineering complaint issues by utilizing various quality...

  • Quality Assurance Specialist

    2 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at Baxter. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesConduct critical chemical and physical analysis on raw materials, initial, in-process, and final...

  • USA - Quality Assurance Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Mindlance Full time

    Position Overview:This document outlines the employment qualifications and responsibilities for the role of Quality Assurance Engineer focused on Complaint Investigations.Key Responsibilities:This role is primarily accountable for the investigation, assessment, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality...

  • Quality Assurance Analyst II

    2 weeks ago

    Lake Bluff, Illinois, United States Experis Full time

    Company Overview:Experis IT ManpowerGroup is collaborating with a prominentMedical Device Companyto fill a critical role in their quality assurance team.Position:Quality Assurance Analyst IILocation:OnsiteContract Duration:12 monthsWorking Hours:Monday to Friday, 8 am - 4 pmCompensation:$28 per hourRole Responsibilities:As a Quality Assurance Analyst, you...

  • Quality Assurance Specialist

    5 days ago

    Crystal Lake, Illinois, United States Technipaq- Crystal Lake Facility Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Technipaq's Crystal Lake Facility. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and maintaining our high standards of excellence.Key ResponsibilitiesPerform routine checks, tests, and inspections of...

  • Quality Assurance Specialist

    1 week ago

    Lake Forest, Illinois, United States Abbott Laboratories Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Abbott Laboratories. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesImplement and maintain the effectiveness of the Quality System, ensuring compliance with...

  • Lead, Supplier Quality Assurance Specialist

    1 day ago

    Round Lake Beach, Illinois, United States Baxter Full time

    About BaxterBaxter is a leading global healthcare company that is committed to improving patient outcomes and saving lives. Our company is built on a legacy of innovation and a passion for delivering high-quality products and services.Your Role at BaxterAs a Lead, Supplier Quality Assurance Specialist, you will play a critical role in ensuring that our...

  • Quality Assurance Specialist

    2 weeks ago

    Lake Zurich, Illinois, United States Schweitzer Engineering Laboratories, Inc. Full time

    Position Overview:This role is designed to enhance manufacturing processes through dedicated quality assurance initiatives. You will engage in problem-solving and process improvement while collaborating with various teams within the organization. A solid technical foundation and the capability to work autonomously are essential for success in this...

  • Quality Assurance Manager

    5 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Baxter. As a key member of our Manufacturing Quality Assurance team, you will be responsible for ensuring the quality and safety of our products and processes.Key ResponsibilitiesManage and coordinate routine activities and projects for an individual cell within the...

  • Quality Assurance Analyst II

    1 week ago

    Lake Bluff, Illinois, United States Experis Full time

    Position Overview:We are seeking a dedicated Quality Assurance Analyst to join our team. This role is essential in ensuring the quality of products and processes in compliance with established operating procedures and industry standards.Key Responsibilities:Conduct thorough analyses of verbal and statistical data to generate comprehensive reports and studies...

  • Quality Assurance Associate

    3 days ago

    Round Lake Beach, Illinois, United States BioSpace, Inc. Full time

    About the RoleThe primary responsibility of this position is to ensure the quality and integrity of our products by overseeing the release and approval of completed documentation for batch folders following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). As a Quality Assurance Associate, you will be accountable for quality oversight...

  • Quality Assurance Automation Engineer

    1 month ago

    Round Lake Beach, Illinois, United States Uline, Inc. Full time

    Quality Assurance Automation EngineerCorporate Headquarters12575 Uline Drive, Pleasant Prairie, WI 53158Keep our growing company running smoothly and efficiently As Uline's Quality Assurance Automation Engineer, implement automated testing and tooling solutions for North America's top distributor of shipping, industrial and packaging materials Maintain the...

  • Software Quality Assurance Specialist

    1 day ago

    Lake Forest, Illinois, United States Precise Solutions Full time

    Job DescriptionPrecise Solutions is seeking a highly skilled Quality Assurance Engineer to join our team in the development of Software as a Medical Device (SaMD) and Digital Health Software products.Key Responsibilities:Represent QA on cross-functional teams and execute Quality System requirements to ensure products are developed, tested, and released in...

  • Regulatory Affairs Operations Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Experis Full time

    Our client, a prominent player in the Healthcare sector, is seeking a Regulatory Affairs Operations Specialist II. In this role, you will be tasked with executing intricate global regulatory strategies, securing and upholding marketing authorizations for products, and conveying essential regulatory requirements to facilitate the licensing of...

  • Quality Assurance Validation Specialist

    2 weeks ago

    Lake Bluff, Illinois, United States Blue Star Partners, LLC Full time

    Job Title: Validation Analyst - C Company: Blue Star Partners, LLC Contract Type: W2 onlyPosition Overview: The Validation Analyst - C will spearhead and assist in validation initiatives and deliverables for projects necessitating validation. This position encompasses the development and execution of validation test scripts, thorough documentation of test...

  • Quality Assurance Inspector

    2 weeks ago

    Crystal Lake, Illinois, United States Accurate Personnel Full time

    Immediate Opening: Quality Assurance InspectorAccurate Personnel is actively seeking a Quality Assurance Inspector to oversee quality control processes. This role involves conducting systematic inspections and evaluations of materials, in-process goods, and final products.The successful candidate will have a solid understanding of quality assurance...

  • Quality Assurance Inspector

    2 weeks ago

    Crystal Lake, Illinois, United States Accurate Personnel Full time

    Immediate Opening: Quality Assurance InspectorAccurate Personnel is actively seeking a Quality Assurance Inspector to support our client. This role involves conducting systematic inspections and evaluations of materials, in-process goods, and final products.The ideal candidate should have a solid understanding of quality assurance principles, experience in...

  • Quality Assurance Inspector

    2 weeks ago

    Crystal Lake, Illinois, United States Accurate Personnel Full time

    Immediate Opening: Quality Assurance InspectorAccurate Personnel is actively seeking a Quality Assurance Inspector to oversee inspection processes. This role involves conducting systematic evaluations and tests on materials, in-process goods, and final products.The successful candidate will have a solid understanding of quality assurance principles,...