Senior Quality Systems Strategist

4 days ago


Warren, Maine, United States Joulé Full time
Job Overview

We are seeking a highly skilled Senior Quality Systems Strategist to lead the development, implementation, and maintenance of globally standardized Quality Management System (QMS) processes.

Key Responsibilities
  • Lead the strategic development and implementation of a robust QMS that aligns with regulatory requirements and organizational goals.
  • Interpret and apply global regulations and standards, including FDA, ISO, EU MDR, and other relevant quality requirements for medical devices and combination products.
  • Collaborate and influence global teams to drive alignment and best practices within the QMS framework.
  • Manage and optimize electronic document management systems to ensure compliance and efficiency.
  • Foster a culture of continuous improvement by challenging the status quo and implementing innovative solutions.
  • Engage with stakeholders across all levels of the organization to promote open communication and collaborative problem-solving.
  • Monitor industry trends and regulatory changes to ensure ongoing compliance and readiness.
Requirements
  • Bachelor's degree in a relevant engineering or scientific field.
  • Minimum of 10 years in Quality, Regulatory Affairs, Manufacturing, or Engineering roles within regulated industries, specifically medical devices or pharmaceuticals.
  • Proven ability to interpret and apply global quality regulations and standards. Significant experience in a manufacturing environment is highly preferred.
  • In-depth knowledge of QMS frameworks and best practices.
  • Strong strategic thinking skills with the ability to maintain a globally standardized QMS.
  • Exceptional leadership, communication, and interpersonal skills.
  • Growth mindset with a focus on driving continuous improvement.
  • Ability to manage multiple projects and priorities effectively.
  • Proficient in relevant PC software applications, including PowerBI.
Benefits

We offer competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.

Compensation

The estimated salary range for this position is $105-130k annually, with a 7% bonus opportunity.



  • Warren, Maine, United States Joulé Full time

    Are you a seasoned professional looking to drive category performance improvements in the electrical space?Joulé is seeking an experienced Senior Electrical Category Strategist to lead our efforts in optimizing and managing the supply chain within high-mix, low-volume manufacturing settings.Role OverviewWe are looking for a skilled leader to develop and...


  • Warren, Maine, United States Joulé Full time

    About JouléJoulé is seeking a seasoned quality assurance professional to lead our embedded software and medical device projects. As Senior Quality Assurance Manager, you will be responsible for ensuring the highest quality standards are met in all aspects of our product development.


  • Warren, Maine, United States Joulé Full time

    At Joulé, we're seeking an experienced Medical Device Quality Assurance Manager to lead our supplier quality programs and ensure compliance with industry regulations. This critical role involves managing supplier quality systems, conducting audits, resolving quality issues, and collaborating across teams to deliver high-quality components.About the RoleWe...


  • Warren, Maine, United States RMH Group Full time

    We are seeking an experienced Electrical Engineer/Project Manager to join our team at RMH Group. With a strong background in the building design industry, this individual will be responsible for technical production tasks on projects, managing client relationships, and leading a team of engineers.ResponsibilitiesOversee project management and client...


  • Warren, Maine, United States Joulé Full time

    Job OverviewAs a Process Excellence Engineer at Joulé, you will play a pivotal role in driving business operations and manufacturing processes forward through process improvement, Lean Six Sigma methodologies, and quality management systems. Your expertise will be instrumental in enhancing product quality and services by leading continuous improvement...


  • Warren, Maine, United States Forte Dynamics Full time

    Job OverviewForte Dynamics is a consulting and engineering firm specializing in mineral resource and reserve estimation, mine planning, blasting analysis, metallurgy, process design, recovery modeling, basic and detailed engineering, and construction management services.Salary & BenefitsWe are seeking an entry-level Mechanical Engineer with a bachelor's...


  • Warren, Maine, United States Joulé Full time

    Job Overview:Joulé is seeking an experienced Business Process Excellence Engineer to join our team. In this role, you will play a crucial part in enhancing our business operations and manufacturing processes through process improvement, Lean Six Sigma methodologies, and quality management systems.


  • Warren, Maine, United States Joulé Full time

    Job Summary:We are seeking a highly skilled Business Operations Excellence Engineer to join our team at Joulé. This role is pivotal in enhancing business operations and manufacturing processes through process improvement, Lean Six Sigma methodologies, and quality management systems.About the Role:The ideal candidate will have over 8 years of experience in...


  • Warren, Massachusetts, United States CIRCOR International Full time

    Job Summary:We are seeking a Senior Quality Assurance Manager to lead our quality process in Warren, MA. The ideal candidate will have 5+ years of experience in quality engineering and be familiar with defense industry requirements.Responsibilities:Lead the development and implementation of quality plans, including inspection steps and sampling plans.Assure...


  • Warren, United States Universal Logistics Holdings, Inc. Full time

    We are looking for a senior system administrator to join our IT team and manage our infrastructure. You will be responsible for installing, configuring, and maintaining servers, workstations, and network devices. You will also troubleshoot issues, implement security policies, and monitor performance.Responsibilities:Install, configure, and update servers,...


  • warren, United States Universal Logistics Holdings, Inc. Full time

    We are looking for a senior system administrator to join our IT team and manage our infrastructure. You will be responsible for installing, configuring, and maintaining servers, workstations, and network devices. You will also troubleshoot issues, implement security policies, and monitor performance.Responsibilities:Install, configure, and update servers,...


  • Warren, Michigan, United States Azzur Group Full time

    Job SummaryWe are seeking an experienced Senior Gas System Specialist to support a project involving commissioning and qualification activities for a modified Gas Distribution System. The ideal candidate will have expertise in gas system qualification, sampling coordination, and end-to-end CQV processes.Estimated Salary: $120,000 - $150,000 per annum.This...


  • Warren, Michigan, United States General Motors Full time

    We are seeking a highly skilled Semiconductor Strategist to lead the strategic selection and development of semiconductors for use across the enterprise at General Motors. This individual will be instrumental in building strong partnerships with internal and external stakeholders, guiding electronics design, and ensuring optimal semiconductor selections for...


  • Warren, Rhode Island, United States We Make RI Partners Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Automation Systems Specialist to join our Advanced Manufacturing Engineering team at We Make RI Partners. In this critical role, you will be responsible for the development and implementation of automated systems within our production process.


  • Warren, Michigan, United States Actalent Full time

    About the RoleWe are seeking an experienced Senior Systems Architect Lead to join our team at Actalent. As a key member of our engineering team, you will be responsible for providing technical leadership and expertise in system architecture design and development.The successful candidate will have a strong background in software architecture design,...


  • Warren, Michigan, United States General Motors Full time

    Job Title: Senior Systems Capability EngineerJob Summary:We are seeking a highly skilled Senior Systems Capability Engineer to join our team at General Motors. As a key member of our engineering team, you will be responsible for designing, developing, and integrating advanced systems for our passenger vehicles, including Battery Electric Vehicle (BEV) and...


  • Warren, Michigan, United States Liberty Personnel Services, Inc Full time

    Job OverviewWe are seeking an experienced Senior Electrical Systems Specialist to join our team at Liberty Personnel Services, Inc.Compensation and BenefitsThe estimated annual salary for this role is $120,000 - $160,000 depending on experience.ResponsibilitiesElectrical Controls Engineer IIThe successful candidate will be responsible for designing,...


  • Warren, Michigan, United States TPI, INC Full time

    Job DescriptionWe are seeking an experienced Senior Automation Systems Engineer to join our Advanced Manufacturing Engineering team. As a key member of the team, you will be responsible for the development and implementation of automated systems within our production process.The ideal candidate has a strong background in automation engineering with a focus...


  • Warren, United States Immucor Inc Full time

    Sr. Quality Assurance Specialist-OperationsJob LocationsUS-NJ-WarrenJob ID2024-3674CategoryQualityOverviewWerfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through...


  • Warren, United States CIRCOR International Full time

    Job Description and Responsibilities JOB TITLE: Senior Quality Engineer - Valves/Pumps (3 Open Positions) BUSINESS: CIRCOR Naval Solutions LOCATION: Warren, MA DIRECT REPORTING: Senior Quality Manager FUNCTIONAL REPORTING: Quality Department POSITION DETAILS Principal Activities Be familiar with stakeholder needs (i.e. customer contracts, regulations,...


  • Warren, Michigan, United States Net2Source Inc. Full time

    Overview:">We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Net2Source Inc.About the Role:">The ideal candidate will have 2+ years of hands-on experience with bioanalytical techniques such as ELISA, Potency, Cell-based assays, etc. in a regulated environment (cGMP, cGLP).Key Responsibilities:">The QC...

  • Chief Data Strategist

    2 weeks ago


    Warren, Michigan, United States Booz Allen Hamilton Full time

    Unlock the Power of DataAt Booz Allen Hamilton, we're on a mission to help organizations transform in today's digital world. As a Senior Data Architect, you'll play a critical role in designing data architecture solutions that drive growth and efficiency.About the RoleAs a Data Architect on our ground combat systems team, you'll use your technical expertise...


  • Warren, Michigan, United States General Motors Full time

    About the RoleWe are seeking an experienced Senior Product Quality Assurance Engineer to join our team. As a key member of our product development process, you will be responsible for ensuring the quality and reliability of our connected features.


  • Warren, Michigan, United States Branex Group Full time

    Seeking a detail-oriented and experienced Automation Execution Engineer to implement, troubleshoot, and optimize automated systems on the production floor.About This RoleWe are looking for a highly skilled professional with expertise in robotics, PLC programming, automated processes, and the development of automation systems from concept through plant...


  • warren, United States Sunrise Systems, Inc. Full time

    Job Title: Sourcing & Procurement AssociateLocation: Warren, NJDuration: 6 Months(Possibility of extension)Purpose and Scope of the PositionOverview: We are seeking a highly motivated and detail-oriented Sourcing and Procurement Associate to join our Strategic Sourcing & Procurement (SS&P) NJ Regional Procurement Team - Cell Therapy R&D facility. The...


  • warren, United States Sunrise Systems, Inc. Full time

    Job Title: Sourcing & Procurement AssociateLocation: Warren, NJDuration: 6 Months(Possibility of extension)Purpose and Scope of the PositionOverview: We are seeking a highly motivated and detail-oriented Sourcing and Procurement Associate to join our Strategic Sourcing & Procurement (SS&P) NJ Regional Procurement Team - Cell Therapy R&D facility. The...

  • Quality Engineer

    2 days ago


    Warren, United States CIRCOR International Full time

    Quality Engineer BUSINESS: CIRCOR Naval Solutions LOCATION: Warren, MA DIRECT REPORTING: Senior Quality Manager FUNCTIONAL REPORTING: Quality Department POSITION DETAILS Principal Activities Be familiar with stakeholder needs (i.e. customer contracts, regulations, requirements) to assure that Quality requirements are built into the production process....


  • Warren, Michigan, United States Verista Full time

    Job DescriptionSenior CSV Engineer Responsibilities:Develop and execute Computer System Validation (CSV) protocols for manufacturing equipment, ensuring regulatory compliance standards are met.Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards.Manage document lifecycles, including...