Senior Quality Systems Engineer

3 weeks ago

Beverly, United States Quanta Dialysis Technologies Full time
Job DescriptionJob Description

Job Title: Sr. Quality Systems Engineer

Company Name: Quanta Dialysis Technologies Inc.

Job Location: Beverly, MA

Job Description:

Responsible for maintaining the Quality Management System for Quanta Dialysis Technology and support with all Quality compliance related activities, including but not limited to, internal audits, regulatory audits, developing processes and procedures and making sure the organization is compliant with the ISO13485, MDSAP, MDR and other regulatory requirements.

Specific duties include:

  • Provide Quality Systems support for sustaining and development projects.
  • Support the organization in developing and updating the Quality Management System (QMS).
  • Provide support and leadership in writing Standard Operating Procedures (SOPs) and Work instructions (WIs) use, maintenance, and repair of biomedical equipment.
  • Support Management review meetings by providing Quality data.
  • Generate weekly and other routine reports for Key Process Indicators (KPI) discussion with the Management.
  • Maintain quality system information databases as assigned.
  • Evaluate quality data and prepare periodic reports to monitor trends.
  • Generate, review, and approve Change requests for Quality Assurance.
  • Manage Employee Training matrix and make sure appropriate assignment of training during hiring process.
  • Perform quality assurance (“QA”), including to meet QMS KPI metrics, and by drafting and reviewing change requests, analyzing and correcting product non-conformities, handling bio-material non-conformities, addressing product quality deviations, and by solving and preventing product problems and failures (all involving biological applications due to product human-clinical use).
  • Support with Monthly Corrective Action Board meetings.
  • Provide guidance and direction to the Quality functions at the various manufacturing facilities which will include supporting CAPA, and Change Control.
  • Support External Regulatory Audits.
  • Perform Internal Audit Schedule and execute Internal Audits.
  • Manage Supplier Quality Metrics.
  • Support with Supplier Agreements and selection and approval of suppliers to add them to the Approved Supplier List.
  • Manage Supplier Audit plans and execution of supplier audits for critical suppliers.
  • Process non-conforming material reports.
  • Ensure any targets set for the business relating to QMS KPI’s are monitored and met where appropriate (e.g. NC, CAPA, complaints resolution, self-training etc.).

Job Requirements:

Requires a Master’s degree in Biomedical Engineering or a related field and three years of experience.

Experience must include:

  • Experience with FDA Quality System Regulation and ISO regulatory requirements.
  • Experience with Regulation 21 CFR Part 820, and applicable international quality standards, such as ISO 13485, MDR, ISO 14971.
  • Experience with part/assembly qualification elements (First Article Inspection, Control plan, FMEA’s, Validations).
  • Development and execution of validation strategies including IQ, OQ, PQ.
  • Statistical process control concepts including Gage R&R & Process Capability.
  • Experience with Supplier qualifications & managing Approved Supplier List.
  • Experience with CAPA, Deviations, Non-conformance, and Complaints.
  • Assessing Manufacturing and Design changes against their impact and supporting the implementation of such changes.

Hybrid remote work permitted; must live within commuting distance of worksite. Travel required to unanticipated worksites nationwide. Travel encompasses up to 15% of time.

  • Lead Quality Systems Engineer

    2 weeks ago

    Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for overseeing the Quality Management System (QMS) at Quanta Dialysis Technologies. This role entails ensuring compliance with various regulatory standards, including...

  • Lead Quality Systems Engineer

    2 weeks ago

    Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for the upkeep of the Quality Management System (QMS) at Quanta Dialysis Technologies. This role encompasses all activities related to Quality compliance, including but not...

  • Lead Quality Systems Engineer

    2 weeks ago

    Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for overseeing the Quality Management System (QMS) at Quanta Dialysis Technologies. This role encompasses supporting various compliance-related activities, including...

  • Senior Quality Supplier Engineer

    3 weeks ago

    Beverly, United States Axcelis Technologies Full time

    Senior Quality Assurance Engineer Want to discover just how far your intellectual curiosity can take you? You're in the right place. For more than four decades, Axcelis Technologies has been at the forefront of innovation in semiconductor manufacturing technology. Chipmakers around the globe rely on our tools and process expertise to deliver the...

  • Senior Software Quality Assurance Engineer

    2 weeks ago

    Beverly, Massachusetts, United States Axcelis Technologies Full time

    Position Overview: The role of a Senior Software Quality Assurance Engineer involves the comprehensive testing of hardware products and software controls associated with Ion Implanters designed for wafer processing at Axcelis Technologies. The ideal candidate will possess a robust background in testing complex electro-mechanical systems. Key...

  • Supplier Quality Engineer/ Medical Device

    3 weeks ago

    Beverly, United States Connexion Systems & Engineering, Inc. Full time $85,000 - $120,000

    Job DescriptionJob DescriptionOur client is looking for a Supplier Quality Engineer this professional will be responsible to maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. ESSENTIAL FUNCTIONS: The...

  • Senior Manufacturing Engineer

    4 weeks ago

    Beverly, United States Connexion Systems & Engineering, Inc. Full time $101,000 - $145,000

    Job DescriptionJob DescriptionSenior Manufacturing Engineer Location: Beverly, MANotes:This is a very "hands-on" role SUMMARY: Plans and coordinates work to higher level project schedules; develops longer term plans under guidance; analyzes complex problems independently, coordinates cross-functional development and supplier work.  Responsible for...

  • Senior Game Systems Engineer

    2 weeks ago

    Beverly Hills, California, United States Snail Games USA Full time

    Job Type: Full-Time We invite you to explore an exciting opportunity at Snail Games USA. Below, you will find a comprehensive overview of the qualifications and responsibilities expected from candidates.Location:Remote This position is fully remote but limited to applicants residing in specific states.Job Overview:The Senior Software Engineer will be...

  • Quality Engineer

    4 weeks ago

    Beverly, United States Michael Page Full time

    Diverse Career OpportunitiesIndustry Leader & Reputation About Our Client My client is a highly regarded company known for its commitment to quality and precision in the manufacturing industry. They specialize in producing high-performance components, particularly in the aerospace sector, where their products are trusted by leading companies. The team is...

  • Senior Electrical Systems Engineer

    2 weeks ago

    Beverly, Massachusetts, United States HCLTech Full time

    The successful applicant will possess a strong background in PD Box/Control systems, selection of Electrical & Electronics components, and familiarity with Industrial sensors and transducers. A comprehensive understanding of System Level Schematics and Interconnect, as well as Analog and Digital signal processing, is essential. Key Responsibilities: Design...

  • Quality Engineer

    2 months ago

    Beverly, United States Goddard Inc. Full time

    Join us as a Quality Engineer and play a crucial role in ensuring our products are developed in compliance with standards, regulations and engineering best practices. You will be a key member of our growing QA and V&V team, upholding the integrity and reliability of our work while making a significant impact on potentially lifesaving products.In this Role,...

  • Senior Software Quality Assurance Engineer

    7 days ago

    Beverly, Massachusetts, United States Axcelis Technologies Full time

    Position Overview: The role of the SQA Engineer encompasses the evaluation of both hardware products and software controls for Ion Implanters designed for wafer processing at Axcelis Technologies. The ideal candidate will possess a robust background in testing complex electro-mechanical systems and product validation. Key Responsibilities: Collaborate within...

  • Senior Software Quality Assurance Engineer

    2 weeks ago

    Beverly, Massachusetts, United States Axcelis Technologies Full time

    Position Overview: The role of the SQA Engineer encompasses the evaluation of hardware products and software controls associated with Ion Implanters designed for wafer processing. The successful candidate will possess a robust background in complex electro-mechanical systems and product evaluation. Key Responsibilities: Collaborate within a team to assess...

  • Quality Engineer

    4 weeks ago

    Beverly Hills, California, United States Michael Page Full time

    Diverse Career OpportunitiesIndustry Leader & Reputation About Our Client My client is a highly regarded company known for its commitment to quality and precision in the manufacturing industry. They specialize in producing high-performance components, particularly in the aerospace sector, where their products are trusted by leading companies. The team is...

  • Supplier Quality Engineer

    2 months ago

    Beverly, United States Microline Surgical Inc. Full time

    Job DescriptionJob DescriptionJOB SUMMARY: Maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential...

  • Senior Operations Engineer

    2 weeks ago

    Beverly, New Jersey, United States Burlington Full time

    OverviewAs a Senior Industrial Engineer at Burlington, you will be instrumental in enhancing operational effectiveness and fostering productivity advancements. Your responsibilities will include establishing and maintaining precise engineered standards, defining and promoting 'Best Practices' across various job roles, and aligning business goals through...

  • Senior Mechanical Engineer

    3 weeks ago

    Beverly, United States Axcelis Technologies Full time

    Axcelis is seeking a mechanical engineer to lead the design and development of highly mechanized and automated capital equipment for the semiconductor industry. Working closely with product and marketing managers, the engineer is responsible for developing innovative solutions to difficult engineering challenges facing ion implanters. Projects may include...

  • Systems Integrator

    6 days ago

    Beverly, United States Nemean Solutions Full time

    Job DescriptionJob DescriptionNemean Solutions, LLC is looking for a Systems Integrator (Systems Engineer).Background:Position SummaryThis is a Systems Integrator (Systems Engineer) position at the TPO-C, National Simulation Center, Fort Leavenworth, KS in support of the National Simulation Center (NSC) Support Operations (SO) task order under MTCCS II...

  • Mechanical Systems Engineer

    7 days ago

    Beverly Hills, California, United States Engtal Full time

    Core Relevant Skills/ExperienceBachelor's degree in mechanical engineering or a related discipline.Proficient in industrial automation techniques.Strong background in mechanical design and DFX, particularly for sheet metal and machining processes.Experience in robotics applications.Capability to produce 2D drawings and implement GD&T standards.Familiarity...

  • Automation Systems Engineer

    2 weeks ago

    Beverly, Massachusetts, United States KROHNE INC Full time

    OVERVIEWThe Automation Systems Engineer is responsible for the proposal, design, implementation, and maintenance of automation systems aimed at enhancing operational efficiency and meeting product specifications. These systems encompass calibration equipment for water-based applications, automated manufacturing machinery in welding assembly and testing, as...