Current jobs related to Quality Management System Engineer - Somerset - Oticon

  • Quality Management System Engineer

    3 weeks ago

    Somerset, United States Oticon Full time

    Job SummaryAs a Quality Management System Engineer at Demant Group Services Operations, you will play a key role in managing the Quality Management System, Quality Engineering functions, internal and external audits, validation, and document control. Your primary responsibilities will include CAPA, NCR, change control, risk management, process review and...

  • Quality Systems Manager

    4 weeks ago

    Somerset, United States Rotor Clip Full time

    Quality Systems ManagerA candidate for Quality Systems Manager should have the skills and qualifications that align with this job description, such as:Thorough understanding of automotive and aerospace quality systems, manufacturing processes, and regulatory requirements.Thorough knowledge of IATF16949, AS9100, ISO9001, ISO13485 and ISO14001. Additionally,...

  • Senior Quality Engineer

    3 weeks ago

    Somerset, New Jersey, United States Veeco Full time

    About VeecoAt Veeco, we're pushing the boundaries of innovation in the semiconductor industry. As a Senior Quality Engineer, you'll play a critical role in driving continuous improvement initiatives, supporting operational effectiveness, and ensuring quality for new and existing products. Our team is passionate about delivering exceptional quality and...

  • Quality Systems IT Specialist

    4 weeks ago

    Somerset, New Jersey, United States Legend Biotech US Full time

    Job Title: Quality Systems IT SpecialistLegend Biotech US is seeking a highly skilled Quality Systems IT Specialist to join our US IT team based in Somerset, NJ.Job Summary:The Quality Systems IT Specialist will be responsible for maintaining various quality and validation applications, including Veeva vault, ComplianceWire, and DocuSign. This role requires...

  • Director of Quality Systems and Compliance

    4 weeks ago

    Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job SummaryThe Director of Quality Systems and Compliance will be responsible for designing, developing, deploying, and maintaining the company's Quality System. This individual will serve as the primary interface with external regulatory agencies for audits and ensure the Quality System is continually compliant with all applicable regulations and...

  • Quality Manager

    2 weeks ago

    Somerset, United States IPS-Integrated Project Services, LLC Full time

    Job Description: At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Quality Manager, Construction to join our talented team at...

  • Quality Manager

    2 weeks ago

    Somerset, United States IPS-Integrated Project Services, LLC Full time

    Job Description: At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Quality Manager, Construction to join our talented team at...

  • Senior Manager, Quality Management Systems

    2 weeks ago

    Somerset, United States Catalent Inc Full time

    Position Summary:Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Manager, Quality Management Systems for the Quality Assurance department. This person will manage a compliance and regulatory team responsible for Compliance and Training activities at the site, which includes overseeing the internal/external audit programs as well as the Training...

  • Senior Quality Engineer

    3 weeks ago

    Somerset, New Jersey, United States Veeco Full time

    Quality Assurance in the Digital AgeWe design, develop, manufacture, and service highly complex, cutting-edge machines used by our customers to create the essential devices that drive the digital age, connect the world, and improve the human experience.As a Senior Quality Engineer at Veeco, you will drive a systems approach into critical quality processes,...

  • Senior Linux Systems Engineer

    4 weeks ago

    Somerset, United States ION GROUP Full time

    Job Title: Senior Linux Systems EngineerWe are seeking a highly skilled Senior Linux Systems Engineer to join our Datacenter Systems team in Somerset, NJ. The ideal candidate will have hands-on experience supporting systems hardware and OS issues in a production systems environment.Key Responsibilities:Administer and manage datacenter systems with working...

  • Software Systems Engineer III

    4 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job SummaryBEUMER Group is seeking a highly skilled Software Systems Engineer III to join our New Jersey-based software development team. As an intermediate-level position, this role offers increased focus on skill specialization, personal autonomy, and team mentorship.Key ResponsibilitiesDevelop, test, and implement software programs that solve complex...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Somerset, New Jersey, United States Omni Inclusive Full time

    Job Title: Senior Quality Assurance EngineerJob Summary:We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Omni Inclusive. As a key member of our software development team, you will be responsible for ensuring the highest quality of our products and services.Key Responsibilities:Develop and execute test plans and test cases...

  • Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States Demant Full time

    Reporting to the Senior Director, Quality Assurance & Regulatory Affairs, the QMS Engineer will play a key role in managing the Quality Management System, Quality Engineering functions, internal and external audits, validation, and document control.Primary areas of responsibility include CAPA, NCR, change control, risk management, process review and approval...

  • Supplier Quality Assurance Engineer

    3 weeks ago

    Somerset, United States Veeco Full time

    Job Summary:We are seeking a skilled Supplier Quality Assurance Engineer to join our team at Veeco. The ideal candidate will have a strong background in quality improvement and risk mitigation, with experience in collaborating with suppliers and contract manufacturing partners.Key Responsibilities: Enable cost down and part quality improvement initiatives in...

  • Quality Assurance Inspector

    4 weeks ago

    Somerset, New Jersey, United States System One Full time

    Job Title: Quality Assurance InspectorJob Summary: We are seeking a Quality Assurance Inspector to join our team at System One. The successful candidate will be responsible for ensuring the quality of our products by conducting inspections, polishing, and bulk packaging of finished goods. Key Responsibilities: • Conduct inspections to ensure compliance...

  • Engineering Manager

    2 months ago

    Somerset, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking an Engineering Manager experienced in leading mechanical teams through ERP system implementations and upfitting manufactured parts into truck bodies or heavy equipment.Job Requirements:Highly prefer BS/MS degree in Mechanical Engineering; 2-year degree candidates consideredExperience leading a mechanical team...

  • Quality Assurance Manager

    4 weeks ago

    Somerset, Wisconsin, United States SMC Ltd Full time

    Job SummarySMC Ltd. is seeking a highly skilled Quality Assurance Manager to lead our quality program and ensure the production of high-quality products. As a key member of our team, you will be responsible for planning, coordinating, and directing quality assurance activities to meet established standards.Key ResponsibilitiesRecruit, select, train, and...

  • Supplier Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job SummaryThe Supplier Quality Engineer (SQE) is a crucial role within BEUMER Group, responsible for ensuring that our suppliers meet our quality standards and requirements. This position involves working closely with suppliers to improve quality, drive continuous improvement, and resolve quality issues that impact the supply chain and project delivery...

  • IT Systems Manager

    3 weeks ago

    Somerset, Wisconsin, United States SMC Ltd Full time

    SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization.We are seeking an IT Systems Manager to oversee and manage systems & solutions, serving as a vital link between IT and business partners to...

  • Quality Compliance Specialist

    4 weeks ago

    Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job SummaryThe Quality Compliance Engineer II is responsible for ensuring the compliance of TMC's products and processes with regulatory requirements. This includes maintaining expertise in quality management standards, software, and tools applicable to Terumo Medical Corporation. The individual will support the management of Health Hazard Evaluations, track...

Quality Management System Engineer

2 months ago

Somerset, United States Oticon Full time
Job Summary

We are seeking a highly skilled Quality Management System Engineer to join our team at Demant Group Services Operations. As a key member of our Quality Assurance & Regulatory Affairs team, you will play a critical role in managing our Quality Management System, ensuring compliance with regulatory requirements, and driving continuous quality improvements.

Key Responsibilities
  • Manage the Quality Management System, including CAPA, NCR, Change Control, Risk Management, and Document Control.
  • Collaborate with internal QA team members and cross-functional departments to support QA activities.
  • Investigate quality issues, implement corrective/preventive actions, and perform effectiveness checks.
  • Develop and maintain Standard Operating Procedures (SOPs), forms, templates, reports, and technical documents.
  • Compile quality metrics for monthly trending, management review meetings, and process improvements.
  • Present and communicate trending reports in Quality forums.
  • Perform training for QA and stakeholders in QMS processes.
  • Identify and implement process improvement projects to drive success in Quality Management Systems.
  • Manage Internal Audit function, including audit planning, execution, and reporting.
Requirements
  • Bachelor's degree in science, engineering, or related discipline.
  • Minimum 3-5 years of relevant Quality Assurance experience.
  • Experience working in Medical Device Manufacturing company preferred.
  • Experience with electronic document management systems, internal audits, and external audits.
  • Strong knowledge of ISO13485, FDA 21 CFR 820, and Document Control Management.
What We Offer

We are an Equal Opportunity / Affirmative Action employer, committed to diversity and inclusion. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.