Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Quality Engineer II

$79.2k - $118.8k

Plug Power

Quality Engineer IIThe Quality Engineer II is a vital team member that supports activities related to the development and continual operation of Plug Power's products. The Quality Engineer II will drive continuous quality improvement through development and use of a customized QMS, KPIs, effective root cause analysis and problem resolution. Enabling optimized decision making by focusing on risk reduction and defect prevention. The position will also be responsible for product environmental, safety and regulatory compliance. The role also requires close interaction with the supply chain, Engineering, manufacturing and other cross-functional departments to ensure that designs meet all cross-functional requirements.Core Duties and ResponsibilitiesEnsures compliance to all Regulatory (Local, Federal, International), Corporate, and Plant standards.Work to thoroughly understand Plug Power's projects including but not limited to relevant codes & standards, hydrogen production technology, customer site requirements, troubleshooting history, design limitations, and optimal system performance targets.With support from internal and external expertise, develop, implement and maintain a certified QMS to ISO 9001:2015. Support Production Part Approval Process (PPAP) and Part Submission Warrant (PSW) preparation.Work with Manufacturing and Engineering teams to develop and revise effective procedures that comply with ISO 9001:2015 QMS requirements while maintaining lean operations.Provide training and support to operations personnel in all aspects of quality.Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.Support Engineering FMEA initiatives with collection of KPI data on critical design features.Participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis; apply root cause analyses using 5Why, Fishbone diagrams etc.; drive implementation of solutions to prevent recurrence of root causes.Execute and document supplier non-conformance reports Supplier Corrective Actions (SCARs) and Corrective and Preventative Actions (CAPAs). Develop inspection plans for incoming material, ensuring parts are inspected per AQL.Work cross functionally with Engineering to evaluate and improve inspection processes and tooling designs through data analysis and feedback loops, aiming for enhanced productivity and quality assurance. Ensure appropriate critical characteristics (per latest Plug procedure EN-0010) cascade in the Process Monitoring Forms as needed to enable compliance to safety, performance and durability product targets.Ensure Production Equipment and Tooling are maintained in the Calibration program. Ensure tooling and equipment is scheduled for calibration at defined intervals. Ensure calibration records are properly maintained.Monitor, communicate and improve key Quality KPI's, DPPM and waste.Support in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis; apply root cause analyses using 5Why, Fishbone diagrams etc.; drive implementation of solutions to prevent recurrence of root causes.Develop and lead in-process inspection capabilities.Lead Material Review Board discussions, determining product dispositions for nonconforming material.Work directly with Quality and Engineering team members to develop and qualify inspection, monitoring, and verification methods.Conduct rigorous Continuous Improvement activities to prevent recurrence of non-conformances during assembly.Perform internal audit activities to ensure compliance to QMS requirements.Build relationships and engage in regular communications with cross-functional colleagues.Represent Plug Power in a professional manner at all times and in all interactions.Perform all other duties as assigned.Education and ExperienceBS in Engineering or a STEM related discipline3-5 years' experience working in EngineeringComputer and software systems skills as applicable to position including but not limited to: Word, PowerPoint, Excel, and OutlookExperience with ISO 9001:2015 or ISO13485 and other recognized international quality system standards.Knowledge of engineering change process.Strong verbal and written communication skillsDemonstrated analytical abilities with strong attention to detailAbility to manage multiple projects concurrently.Ability to read and interpret engineering diagrams.Ability to role model high standards of professionalism with an uncompromising dedication to quality design & documentation and operational safety.Knowledge of quality system methodologies including 8D, Lean, 5 Why's, Pareto Analysis, Six Sigma, 8-D.Knowledge with implementation Statistical Process Controls, applying Failure Modes Effects Analysis (FMEA), Production Part Approval Process (PPAP) and root cause analysis are a plus.Strong problem-solving skills.Strong organizational skills.Project management skills.Attention to detail.Travel as needed to accomplish program objectives.Plug Power, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Estimated Base Salary Range:$79,200.00 - $118,800.00

Vacancy posted 9 hours ago
Similar jobs that could be interesting for youBased on the Quality Engineer II in Concord, MA vacancy
  • $66k - $88k

     ...world impact, and you'll be supported in achieving your career goals. DESCRIPTION How will you make an impact? As a Quality Engineer, II, you will be responsible for facilitating the Investigation and CAPA process to enable the site to reduce the number of... 
    Suggested
    Temporary work
    Work at office

    Thermo Fisher Scientific

    Bedford, MA
    2 days ago
  •  ...Quality Engineer IIPramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary...  ...achieve better outcomes.Position SummaryThe Quality Engineer II is an intermediate level role. They will serve as a technical... 
    Suggested
    Work experience placement
    Worldwide

    Pramand

    Bedford, MA
    9 hours ago
  • What You’ll DoThe Quality Engineer will provide support for manufacturing commercial products through review and approval of Change Controls, CAPAs and Deviations. Support new product development as needed. The Quality Engineer participates in customer and regulatory audits... 
    Suggested
    Full time
    Immediate start

    Anika

    Bedford, MA
    8 hours ago
  • Pramand, LLC, based in Bedford, MA, is seeking a Quality Engineer II to support QA/QC for implantable medical devices. You will lead day-to-day quality activities, participate in design controls, and ensure compliance with cGMP, ISO 13485, and 21 CFR Part 820. You will... 
    Suggested

    Pramand-LL

    Bedford, MA
    1 day ago
  • $85k - $105k

    Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility in Allston next year)Schedule: Onsite 5 days/week with future hybrid flexibility following relocationCompensation: $85,000 - $105,000 base salary + bonus + stock optionsJoin... 
    Suggested
    Relocation

    Real Staffing Group

    Woburn, MA
    2 days ago
  • $65k - $113.75k

     ...QA Automation Engineer IIWork as a key member of a Scrum team to execute the overall quality plan for one of Charles River's products. Provide support and assistance to customers...  ...you are up for.As QA Automation Engineer II you will:Work closely with the scrum master, product... 
    Temporary work

    State Street Corporation

    Burlington, MA
    2 days ago
  •  ...asset management. Our founders are hardcore telecommunications engineers with combined 200 + years of experience in designing, optimizing...  ...HDMI, Component, Composite and S-video Familiarity with HP Quality Center Experience writing test cases and test plans Strong verbal... 

    AmNet Services

    Waltham, MA
    2 days ago
  • $117.7k - $176.5k

    Job SummaryThe Staff Design Quality Assurance Engineer is a senior quality leader responsible for ensuring compliant design controls, risk management...  ...Control and Quality Engineering activities for FDA Class II and III medical devices, ensuring complete and compliant Design... 
    Full time
    Work at office

    Insulet Corporation

    Acton, MA
    4 days ago
  •  ...Software Quality Assurance EngineerWingbrace is a software and technical services company focused on the delivery of solutions for our...  ...government and large corporate partners.As a Software Quality Assurance Engineer at Wingbrace, you will be: This is an opportunity for a... 
    For subcontractor
    Flexible hours

    Wingbrace

    Lincoln, MA
    5 days ago
  • $90.2k - $112.8k

     ...quo to continually find a better way. You will experience these qualities of passion, pride and aspiration in many ways — from a rich...  ...RoleWe are seeking a Senior Automation and AI-Driven Quality Engineer to design, implement, and scale intelligent quality, automation... 
    Full time
    Shift work

    Aspen Technology

    Bedford, MA
    4 days ago
  • $87.3k - $130.95k

    Job SummaryThe Senior Quality Assurance Engineer is responsible for ensuring quality, compliance, and continuous improvement within the manufacturing of Insulet’s Omnipod medical devices. This role supports new product introductions, manufacturing equipment implementation... 
    Full time
    Contract work
    Work at office
    Worldwide

    Insulet Corporation

    Acton, MA
    1 day ago
  • $87.1k - $130.6k

    Job SummaryThis role is focused on managing and improving supplier quality for metal components used in medical devices. The Supplier Quality Engineer works closely with suppliers and internal teams to ensure products meet quality and regulatory requirements, drive supplier... 
    Full time
    For contractors
    Work experience placement
    Work at office

    Insulet Corporation

    Acton, MA
    2 days ago
  • $130k - $160k

     ...commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the...  ...Overview Position Summary: The Senior Software Quality Engineer position is responsible to ensure that activities throughout... 
    Full time
    Work experience placement
    Worldwide
    Shift work

    Werfen

    Bedford, MA
    2 days ago
  • $160k - $180k

     ...Overview Position Summary: Using Engineering procedures standard for research and development, carries out assignments associated with...  ...documentation Review test cases, automation scripts, and test code for quality and accuracy Assess existing test processes and recommend... 

    Unavailable

    Bedford, MA
    1 day ago
  • $103k - $163k

     ...The Supplier Quality Engineer is a key member of Philips' Image Guided Therapy Devices (IGTD) Quality team, responsible for driving supplier performance and continuous/process improvement, striving for continuous quality improvement throughout the product lifecycle, and... 
    Full time
    Work at office
    Local area
    Work visa
    Relocation package
    3 days per week

    Philips

    Bedford, MA
    4 days ago
  •  ...energy, and process and monitoring applications for defense, industrial, and commercial customers worldwide. The Supplier Quality Engineer develops, documents and directs the implementation and evaluation of quality assurance programs and systems on one or more large... 
    Worldwide

    General Atomics

    Acton, MA
    19 hours ago
  •  ...Sr. Supplier Quality EngineerContract Duration: 12 Months Location: Bedford, MA 01730Local candidates to the Bedford MA required. Pay...  ...contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/or SQE with this hands-on experience in... 

    Careers Integrated Resources Inc

    Bedford, MA
    9 hours ago
  • $100k - $130k

     ...We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components...  ...fit for our team! Position Summary: The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies... 
    Work at office

    Cirtec Medical

    Lowell, MA
    2 days ago
  • $120k - $140k

     ...Senior Supplier Quality Engineer Bedford, Massachusetts, US 6884995 a day ago Job Description Job Title : Senior Supplier Quality Engineer Location : Bedford, MA Schedule : Monday - Friday Pay Range : $120-140k annually We are seeking an accomplished Senior Supplier Quality... 
    Work at office
    Monday to Friday

    USPRO

    Bedford, MA
    3 days ago
  • RTX is seeking a Mechanical Engineer II in the Test Solutions Center to design, develop, document, and maintain complex test environment systems for Raytheon products. The role is based on-site in Tewksbury/Andover, MA, with a focus on reliability and integration within... 
    Relocation

    Prattwhitney

    Sudbury, MA
    2 days ago
  • Raytheon in Massachusetts seeks a Mechanical Engineer II to design, develop, document, and maintain complex test environment systems for all Raytheon products. The role is hands-on, integrating state-of-the-art test solutions with engineering systems in labs, field, and... 

    Raytheon

    Tewksbury, MA
    1 day ago
  • RTX in Massachusetts seeks a Senior Software Test Engineer to join the Patriot Software Team in Tewksbury. You will analyze requirements, design and execute test cases (manual and automated), and collaborate with developers to ensure secure, reliable software for the Patriot... 
    Relocation package
    Afternoon shift

    Prattwhitney

    Concord, MA
    4 days ago
  • $86.8k - $165.2k

     ...and find new ways to connect and protect our world. Raytheon brings the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. We deliver solutions that help our nation and... 
    Temporary work
    Work experience placement
    Interim role
    Relocation package
    Flexible hours
    Shift work

    Prattwhitney

    Concord, MA
    4 days ago
  •  ...Job Description About the Team: The Quality Team in Newton, NC supports the...  ...Quality Manager, this team of four quality engineers partners with leadership to plan, implement...  ...Be part of our ZF team as Engineer II - Supplier Quality and apply now! DIVERSITY... 

    ZF Friedrichshafen

    Newton, MA
    more than 2 months ago
  • $111k - $145k

     ...Description Scientific Systems is seeking an experienced QA & Test Engineer to design, execute, and maintain comprehensive test programs...  ..., and data‑driven defect analysis. You will help shape the quality foundation for a new generation of autonomy products deployed... 
    Temporary work
    Summer work

    Scientific Systems Company, Inc.

    Burlington, MA
    2 days ago
  • $102.48k - $163.97k

    JOB DESCRIPTION Job Title Quality Systems Engineer Job Description ​ The Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance... 
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Bedford, MA
    a month ago
  • $102.48k - $163.97k

     ...The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software... 
    Full time
    Work at office
    Local area
    Work visa
    Relocation package
    3 days per week

    Philips

    Bedford, MA
    5 days ago
  • $115k - $182k

    JOB DESCRIPTION Job Title Software Test Engineer - Medical Device Integration (Bedford, MA) Job Description Software Test...  ...requirements are complete, clear, and testable. Supports high-quality delivery by validating requirements readiness. Develops and... 
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Bedford, MA
    more than 2 months ago
  • Honeywell INC. is seeking a Quality Engineer Technician to support quality assurance and control activities within manufacturing. Based in Acton, MA, you will perform inspections, data analysis, and continuous improvement initiatives on-site, reporting to the Quality Engineer... 

    Honeywell INC.

    Acton, MA
    5 days ago
  •  ...and Responsibilities: The Manufacturing Engineering role is central to maintaining and...  ...work cross-functionally with Production, Quality, R&D, Regulatory Affairs, and Supply Chain...  ...manufacturing. Experience with Class II or Class III medical device manufacturing... 

    Instylla , Inc.

    Bedford, MA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Engineer II. Be the first to apply!