System Validation Manager

4 days ago

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

We are seeking a System Validation Manager to join our team at Demant Group Services Operations in Somerset, NJ.

This is an exciting opportunity to work with a leading company in the medical device industry, ensuring that all products and processes meet regulatory requirements.

As a System Validation Manager, you will play a key role in developing and implementing validation protocols, ensuring compliance with relevant regulations such as FDA 21 CFR 820 and ISO 13485.

You will also be responsible for conducting validation activities, 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 system validation, we encourage you to apply for this exciting opportunity.

Responsibilities
  • Develop and implement validation protocols to ensure compliance with regulatory requirements.
  • Conduct validation activities 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 System Validation, 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

$105,000 - $125,000 per year, depending on experience.

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

  • SAP Quality Management Systems Specialist

    7 days 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...

  • Community Outreach Manager

    2 days ago

    Somerset, New Jersey, United States Alternatives Inc. Full time

    Position SummaryThis is an exciting opportunity to join our team as a Case Manager at Alternatives Inc. You will work directly with homeless women and their children, providing personalized support and guidance to help them achieve stability and independence.Duties and ResponsibilitiesAssess client needs and develop tailored plans to address these...

  • Geographic Information System Specialist

    3 weeks ago

    Somerset, New Jersey, United States US Tech Solutions Full time

    About the RoleWe are seeking an experienced GIS Technician to join our team at US Tech Solutions. This is a key position within our organization, responsible for maintaining and updating our GIS connected model, analyzing data, and preparing reports and maps that inform business decisions.Key ResponsibilitiesMaintain and update our GIS connected model with...

  • SAP Financial Systems Expert

    3 weeks ago

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

    Job Overview: Terumo Medical Corporation is seeking a highly skilled SAP FICO Specialist to join our team. This role will be responsible for designing, implementing, and supporting financial solutions in SAP S/4 HANA.Key Responsibilities:Accountable for the design and implementation of end-to-end solutions for finance functions in Accounts Receivable,...

  • Software Systems Development Specialist

    3 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job DescriptionCompany Overview: BEUMER Group is an international manufacturing leader in intralogistics, providing innovative solutions for conveying, loading, palletizing, packaging, sortation, and distribution technology.Job Summary: We are seeking a skilled Software Systems Engineer III to join our New Jersey-based software development team. This...

  • Logistics Systems Director

    3 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job OverviewWe are seeking a highly skilled Logistics Systems Director to lead our North American team in providing best-in-class intralogistics solutions.About the RoleThis is a high-visibility, high-impact leadership role responsible for conceptualizing and co-architecting with customers in North America to provide top-notch intralogistics solutions based...

  • IT Systems Architect

    5 days ago

    Somerset, New Jersey, United States SHI GmbH Full time

    OverviewSHI GmbH is a global provider of IT solutions and services, helping organizations change the world through technology. Our team consists of over 6,000 employees worldwide, dedicated to delivering exceptional results. As an Enterprise Security Engineer at SHI GmbH, you will play a crucial role in shaping our identity access management practices.

  • Warehouse Operations Manager

    3 weeks ago

    Somerset, New Jersey, United States Jobot Full time

    Job Overview:Jobot is seeking a skilled and experienced Warehouse Supervisor to oversee warehouse operations and ensure efficient and effective distribution processes for our client, a prominent manufacturing company.Responsibilities:Supervise daily warehouse operations, including receiving, storing, inventory management, and shipping of goods.Ensure...

  • Logistics Coordination Manager

    6 days ago

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

    Job Description: Logistics Coordination ManagerWe are seeking a skilled Logistics Coordination Manager to join our team at Terumo Medical Corporation. As a Logistics Coordination Manager, you will be responsible for coordinating logistics activities across multiple field-based locations, ensuring timely and accurate delivery of inventory, and maintaining...

  • Facilities Maintenance Manager for Food Production

    3 weeks ago

    Somerset, New Jersey, United States PIM Brands, Inc Full time

    Job OverviewPIM Brands, Inc. is seeking a skilled Facilities Maintenance Manager for Food Production to join our team at PIM's Pierce Site in Somerset, NJ.ResponsibilitiesOversee and coordinate the day-to-day maintenance and repair of buildings, grounds, and utilities services to ensure safe and reliable operation of facilities.Supervise staff and...

  • Warehouse Operations Manager

    3 weeks ago

    Somerset, New Jersey, United States Promotion In Motion Full time

    About UsPromotion In Motion is a dynamic and rapidly growing company that produces iconic snack and confectionery brands. Our portfolio of products includes Welch's Fruit Snacks, Sun-Maid Chocolate Raisins, and Sour Jacks Sour Candies.Job OverviewWe are seeking a highly skilled Warehouse Operations Manager to join our team at our Somerset, NJ location. This...

  • Clinical Supply Chain Manager

    2 weeks ago

    Somerset, New Jersey, United States BAP Pharma Full time

    Job DescriptionWe are seeking a highly skilled Clinical Supply Chain Manager to join our team in Somerset, New Jersey. As a key member of our logistics team, you will be responsible for coordinating all logistics-related aspects of clinical supply packaging and labelling projects.Your main responsibilities will include:Managing client inventory...

  • Warehouse Operations Manager

    3 weeks ago

    Somerset, New Jersey, United States Jobot Full time

    We are seeking a skilled Warehouse Supervisor to oversee warehouse operations and ensure efficient distribution processes. As a key member of our team, you will be responsible for supervising daily warehouse activities, including receiving, storing, inventory management, and shipping of goods. You will also ensure compliance with safety regulations and...

  • Administrative Project Manager

    4 days ago

    Somerset, New Jersey, United States BEUMER Group Full time

    About the Role:We are seeking an Administrative Project Manager to join our team at BEUMER Group. In this role, you will be responsible for coordinating projects, managing timelines, and ensuring that all tasks are completed efficiently and effectively. If you have strong organizational skills, attention to detail, and excellent communication skills, we...

  • Corporate Talent Acquisition Manager

    2 weeks ago

    Somerset, New Jersey, United States Employvision Inc. Full time

    About the RoleThis Corporate Talent Acquisition Manager position at Employvision Inc. in Somerset, NJ offers a unique opportunity to leverage your expertise in recruitment and talent management to drive business growth.The successful candidate will develop and implement effective recruitment strategies, manage the full-cycle recruitment process, and build...

  • Supplier Performance Improvement Manager

    5 days ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Role SummaryWe are seeking an experienced Quality Management Engineer to join our team at BEUMER Group. This role will focus on ensuring that our suppliers meet our quality standards and requirements, and will involve evaluating and selecting suppliers, developing quality assurance processes, and driving continuous improvement initiatives with our...

  • Technical Operations Manager

    3 weeks ago

    Somerset, New Jersey, United States Demant Full time

    About Demant">Demant is a world-leading hearing healthcare group with over a century of experience in developing innovative technologies to improve people's hearing and health.">We operate in a global market with companies in more than 30 countries, employing over 14,500 staff and generating annual revenue of approximately $2.1 billion.">The role of the...

  • Manufacturing Finance Manager

    2 weeks ago

    Somerset, New Jersey, United States US2160 Sysco Guest Supply, LLC Full time

    About the RoleWe are seeking a highly skilled Manufacturing Finance Manager to join our team at US2160 Sysco Guest Supply, LLC. This role will play a critical part in driving increased profitability, process efficiency, and overall business improvement.Key ResponsibilitiesFinancial Planning and Analysis: Develop and maintain operating metrics for...

  • Site Installation Supervisor II

    3 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    **Overview**BEUMER Group is a leading international manufacturing company in intralogistics, specializing in conveying, loading, palletizing, packaging, sortation, and distribution technology. We offer innovative solutions for almost every logistical challenge.**About the Role**We are seeking an experienced Site Installation Supervisor II to join our team as...

  • Nursing Supervisor

    3 weeks ago

    Somerset, New Jersey, United States RWJBarnabas Health Corporate Services Full time

    Job Overview:">Nursing supervisors with leadership skills are needed to oversee patient transfers and provide comprehensive care coordination. As a clinical coordinator, you will work closely with staff physicians and leaders to promote a positive and supportive environment.">Key Responsibilities:">">Provide comprehensive care coordination for patients...