Quality Assurance Specialist

3 weeks ago

Somerset, New Jersey, United States Oticon Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Demant Group Services Operations in Somerset, NJ. This is a unique opportunity to work with a leading company in the medical device industry.

The ideal candidate will have a strong background in quality management systems and regulatory compliance, with experience working in a similar role.

As a Quality Assurance Specialist, you will play a key role in managing our Quality Management System, ensuring that all processes and procedures are compliant with relevant regulations such as FDA 21 CFR 820 and ISO 13485.

You will also be responsible for conducting internal audits, reviewing and evaluating corrective/preventive actions (CAPA), and maintaining documentation control.

In addition, you will support the development and implementation of quality metrics and reports, and participate in external notified body audits.

This is a challenging and rewarding role that requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities.

If you are a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply for this exciting opportunity.

Responsibilities
  • Manage and maintain the Quality Management System, including CAPA, Document Control, and Training programs.
  • Conduct internal audits and reviews of corrective/preventive actions (CAPA) to ensure compliance with regulatory requirements.
  • Maintain accurate and up-to-date documentation, including Standard Operating Procedures (SOPs), forms, templates, and technical documents.
  • Develop and implement quality metrics and reports to track performance and identify areas for improvement.
  • Participate in external notified body audits to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to develop and implement process improvements and resolve quality issues.
Requirements
  • Bachelor's degree in Science, Engineering, or related discipline.
  • Minimum of 3-5 years of experience in Quality Assurance, preferably in the medical device industry.
  • Experience working with electronic document management systems and conducting internal audits.
  • Strong knowledge of regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
  • Excellent communication and collaboration skills, with ability to work effectively in a team environment.
Salary and Benefits

$95,000 - $110,000 per year, depending on experience.

Comprehensive benefits package, including health insurance, retirement plan, and paid time off.

  • Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States Medvacon Life Sciences Full time

    Job Overview:As a Quality Assurance Specialist at Medvacon Life Sciences, you will play a vital role in ensuring the quality and compliance of our pharmaceutical manufacturing facility. This is a temporary contracted position lasting 6 months, working on-site from Monday to Friday, 8:30 AM to 5 PM.Key Responsibilities:- Conduct audits to ensure compliance...

  • Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States On-Board Companies Full time

    At On-Board Companies, we are seeking a Quality Assurance Specialist to join our team. As a key member of our organization, you will play a vital role in ensuring the quality and compliance of our manufacturing processes.This is a full-time position based out of New Brunswick/Somerset, NJ area. The estimated salary for this position is $25-$35 per hour.About...

  • Software Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States Omni Inclusive Full time

    Join Omni Inclusive as a Software Quality Assurance Specialist and take on the challenge of ensuring the highest quality of our software products. As a member of our team, you will develop and execute test plans, identify defects, and collaborate with cross-functional teams to resolve issues.Job OverviewWe are seeking a highly skilled Software Quality...

  • Senior Quality Assurance Specialist for Manufacturing

    4 weeks ago

    Somerset, New Jersey, United States JobsRUs Full time

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our client in Somerset, NJ.Compensation and BenefitsThe successful candidate will receive a competitive salary of $40.00/hour, paid weekly, along with various benefits available.About the RoleIn this key position, you will be responsible for providing technical support to...

  • Quality Assurance Engineer

    2 weeks ago

    Somerset, New Jersey, United States Trotter Workforce Full time

    Job Summary:Trotter Workforce is seeking a Quality Assurance Engineer to join our team in Somerset, NJ. As a Quality Assurance Engineer - Somerset, NJ, you will be responsible for ensuring the quality and safety of our products throughout the entire production process.Key Responsibilities:Develop and implement quality control procedures to ensure...

  • Laboratory Quality Assurance Specialist

    2 weeks ago

    Somerset, New Jersey, United States JobsRUs Full time

    Job DescriptionWe are seeking an experienced and dedicated Quality Control Laboratory Technician to join our team at JobsRUs.com. in Somerset, NJ.Salary: $24.00 per hourJob OverviewThe successful candidate will maintain quality standards by approving incoming materials, finished products, and recording the results. This role requires excellent communication...

  • Laboratory Quality Assurance Specialist

    3 weeks ago

    Somerset, New Jersey, United States Integrated Resources, Inc ( IRI ) Full time

    Quality Control Laboratory TechnicianAbout the Job:This role involves performing complex laboratory activities, including analytical tasks and sample preparation. The successful candidate will ensure compliance with safety protocols and procedures, while maintaining accurate records and documentation.Responsibilities:Perform routine and non-routine...

  • Production Quality Assurance Specialist

    2 weeks ago

    Somerset, New Jersey, United States Trotter Workforce Full time

    Job Overview:Somerset, NJ

  • Conformity Assurance Inspector

    2 weeks ago

    Somerset, New Jersey, United States Paragon Staffing, LLC Full time

    Job Summary:We are seeking a skilled Quality Assurance Auditor to join our team at Paragon Staffing, LLC. As a Quality Assurance Auditor, you will be responsible for ensuring the quality of products manufactured at our client's facilities.**Job Responsibilities:**Evaluate and mitigate defects by assessing part quality, process quality, and material...

  • SAP Quality Management Systems Specialist

    4 weeks ago

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

    About Terumo Medical Corporation">Terumo Medical Corporation is a leading medical device manufacturer seeking an experienced SAP Quality Management Specialist to join our team. As a member of our quality management team, you will play a critical role in designing, developing, and deploying SAP S/4HANA solutions to meet business unit needs for quality...

  • Manufacturing Quality Control Associate

    2 weeks ago

    Somerset, New Jersey, United States Paragon Staffing, LLC Full time

    About the JobWe are seeking a highly detail-oriented Quality Assurance Auditor to join our team at Paragon Staffing, LLC.Salary Range:$24-$26 per hourKey ResponsibilitiesYou will be responsible for conducting regular inspections on parts to ensure conformity and performing dock audits to prevent non-conforming products from reaching customers.Core...

  • Quality Process Design and Deployment Expert

    4 weeks ago

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

    About This Opportunity">We are seeking an experienced SAP Quality Management Specialist to join our team at Terumo Medical Corporation. As a member of our quality management team, you will be responsible for designing, developing, and deploying SAP S/4HANA solutions to meet business unit needs for quality management processes.">Key...

  • Cleaning Specialist

    2 weeks ago

    Somerset, New Jersey, United States Manpower Group Inc. Full time

    Job Title:Cleaning SpecialistAbout the Role:We are seeking a reliable and detail-oriented Cleaning Specialist to join our team in Somerset, NJ. As a Cleaning Specialist, you will play a crucial role in maintaining cleanliness and hygiene in our manufacturing environment.Responsibilities:Refurbish water coolers by cleaning and detailing them to meet quality...

  • Project Management Specialist

    3 weeks ago

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

    Job DescriptionWe are seeking a dedicated Senior Project Engineer, Project Controls to join our team at IPS-Integrated Project Services, LLC in Somerset, New Jersey.In this role, you will be assigned to projects to review, coordinate and summarize the activities of cost control, planning and scheduling, document control, and estimating. You will also support...

  • Maintenance Specialist

    2 weeks ago

    Somerset, New Jersey, United States The Park at Franklin Full time

    Job Title: Maintenance SpecialistWe are seeking a highly skilled Maintenance Specialist to join our team at The Park at Franklin. As a key member of our maintenance staff, you will be responsible for ensuring the overall upkeep and repair of our community facilities and grounds.Responsibilities include receiving and completing work orders, communicating with...

  • Installation Supervisor Specialist

    3 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    About the RoleWe are looking for an experienced Installation Supervisor Specialist to oversee mechanical installation activities on-site for BEUMER system projects. This individual will be responsible for ensuring that high-quality work is provided in a safe manner.The estimated salary for this position is $85,000 - $115,000 per year, depending on...

  • Packaging Operations Specialist

    3 weeks ago

    Somerset, New Jersey, United States PIM Brands , LLC Defunct Full time

    Packaging Operations SpecialistAt PIM Brands, LLC Defunct, we are seeking a skilled Packaging Operations Specialist to join our team. As a Packaging Operations Specialist, you will play a crucial role in supporting packaging room employees on their day-to-day responsibilities.About the Role:This position is responsible for recording accurate...

  • Pediatric Healthcare Specialist

    4 weeks ago

    Somerset, New Jersey, United States BAYADA Home Health Care Full time

    About This OpportunityBAYADA Home Health Care is seeking a skilled Pediatric Healthcare Specialist to join our team in Somerset, New Jersey.Job OverviewWe are dedicated to providing high-quality care to clients of all ages and acuity levels. Our Pediatric Healthcare Specialists work closely with clients and their families to develop personalized care plans...

  • Business Office Support Specialist

    2 weeks ago

    Somerset, New Jersey, United States SCA Health Full time

    About UsSCA Health is a dynamic organization with 11,000 teammates who care for over 1 million patients annually. We support physician specialists in various aspects of patient care, aligning them with health plans and systems to deliver high-quality outcomes at a lower total cost of care.

  • Production Encapsulation Specialist

    4 weeks ago

    Somerset, New Jersey, United States System One Full time

    Job Title: Production Encapsulation SpecialistWe are seeking a skilled Production Encapsulation Specialist to join our team at System One in Somerset, NJ.Salary: $60,000 - $80,000 per yearJob Description:The Production Encapsulation Specialist is responsible for assembling, disassembling, troubleshooting, and cleaning encapsulation parts, pumps, and...