Sr Quality Compliance Engineer

2 weeks ago


Trenton, United States Terumo Medical Corporation Full time

Job Summary The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutical, and software products through collaborative partnerships and out-reach with cross-functional departments. This includes but is not limited to: FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation 745/2017, and MDSAP Country requirements.

Job Details/Responsibilities Ensure TMC is effectively monitoring for all new and revised external regulations and standards. Partner with Quality Compliance Process Manager to establish time-bound product plans to conduct gap assessments and remediation activities within the required timeframes. Provide Regulation and Standard Management assistance to the organization as required. Assist management on development, implementation, and maintenance of Quality Performance Indicators for Standards management and dashboard to monitor product/process compliance to the most up-to-date requirements. Collaborate with Post-Market Surveillance team to establish a robust process for overseeing the management of all post-market sustaining activities required to maintain global market access. Monitor to ensure input from cross-functional teams required for PMSP, PSUR, PMCF, CEP, and CERs is being provided in accordance with the established schedule. Escalate issues impacting the timeliness of the post-market requirements and external standard deliverables to management. Coach, mentor, and cross-train less experienced staff on the skills and competency required to successfully perform their responsibilities. Support TMC sites and subsidiaries on compliance and quality related issues. Participate on product design teams and verify compliance to applicable regulations and external standards. Coordinate input from various stakeholders, such as Medical Affairs and PMS, required to draft Health Hazards Evaluations and ensure information provided to the Critical Action Committee meeting is complete and accurate. Partner with cross-functional teams on projects (NPD, Sustaining, Acquisition) as a Compliance SME, including the role of: Independent reviewer on design control projects to ensure compliance with internal regulations and external standards. Drive Quality System or product enhancement projects associated with regulatory changes. Review and draft proposed changes to Quality System procedures/forms as required to maintain compliance and improve overall efficiency and effectiveness. Perform other job-related tasks as assigned. Knowledge, Skills and Abilities (KSA) Practical experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements, preferably for medical devices. Solid analytical and critical thinking skills. Demonstrated ability to effectively communicate with all levels of the organization including Executive Leadership. Ability to provide clear direction to others. Strong interpersonal skills with the capability to influence cross functional collaboration. Effective proofreading and writing skills. Strong organizational and prioritization skills. Ability to navigate the grey. Demonstrated decision-making skills including the ability to rapidly understand complex changes and pace work completion to the needs of the company. Independent decision-making on routine business tasks. Proven ability to multi-task and deliver timely results. Proficient computer knowledge (MS Office) Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Qualifications/ Background Experiences B.S. degree or equivalent in Scientific or Engineering discipline required. Master’s degree in science or engineering preferred. Minimum of 5 to 8 years overall experience in a regulated industry, specifically medical device/diagnostic, pharmaceutical with focus on Quality System Regulations

#J-18808-Ljbffr



  • Trenton, United States CareerBuilder Full time

    Job Summary The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutical, and software products through collaborative partnerships and out-reach with...


  • Trenton, United States Fiserv Full time

    Our software engineers at Fiserv bring an open and creative mindset to a global team developing mobile applications, user interfaces and much more to deliver industry-leading financial services technologies to our clients. Our talented technology team members solve challenging problems quickly and with quality. We're seeking individuals who can create...

  • Quality Engineer 2

    1 day ago


    Trenton, United States Pacer Staffing Full time

    Title: Quality Engineer 2 Location: Flanders NJ USA 07836 Duration: 10+ Months (Possible Extension) Shift Hours: Mon – Fri (8am to 5pm) Job Description This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional...


  • Trenton, United States CareerBuilder Full time

    Sr. Project Engineer Department: Engineering Employment Type: Full Time Location: Philadelphia Branch Reporting To: Project Executive/ Project Manager Description Torcon is seeking Project Engineers with 5 to 8 years of experience in the construction industry. The Project Engineer will be responsible for evaluation of submittals and RFIs to support...


  • Trenton, United States DevSelect Full time

    Title: Sr. Network Security Engineer Location: New Jersey Openings: 2 Type: Long-Term Contract Looking for a highly motivated, experienced Sr. Network Security Engineer. Individual needs to be highly technical and analytical with strong verbal and written communication skills. One or more of the following certifications is highly desired; CSSP, CISSP, CCSK,...

  • Quality Engineer

    5 days ago


    Trenton, United States ALLTECH CONSULTING SVC INC Full time

    Responsibilities:* Provide high-level test effort estimate* Create detailed and well-structured test plans and test cases* Set up a test harness to test functionality* Automation feasibility study, development & maintenance of API, functional, integration and load/performance scripts across platforms* Build, deploy application & conduct manual and automated...


  • Trenton, United States L3Harris Technologies Full time

    Aerojet Rocketdyne, an L3Harris Technologies Company, is seeking a Specialist, Quality Engineer at our AMF site located in Toney, AL. Responsible for the design, development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision and accuracy of company products in compliance with contractual and...

  • Quality Engineer

    6 days ago


    Trenton, United States ALLTECH CONSULTING SVC INC Full time

    Responsibilities: * Provide high-level test effort estimate * Create detailed and well-structured test plans and test cases * Set up a test harness to test functionality * Automation feasibility study, development & maintenance of API, functional, integration and load/performance scripts across platforms * Build, deploy application & conduct manual and...

  • Engineer

    6 days ago


    Trenton, United States Automann USA, Inc. Full time

    Education: Sr. Mechanical Engineer, Master’s degree in Mechanical Engineering with 2 years of experience Deadline: 2024 years ago Sr. Mechanical Engineer, Master’s degree in Mechanical Engineering with 2 years of experience Implement PPAP (Product Part Approval Process) and produce first article inspection reports to record the design, development, and...


  • Trenton, United States Reperio Human Capital Full time

    Job Description: We're looking to bring on an experienced Sr. Fullstack Engineer to help modernize our client's technology stack. You will be working on a wide range of projects, including developing microservices, creating user-friendly and visually appealing interfaces, and expanding into new markets. Required Qualifications: Minimum 5 years of experience...

  • Sr. Associate

    2 weeks ago


    Trenton, United States ValueMomentum Full time

    Job Title: Sr. Associate – Quality Assurance Location of the Job: PISCATAWAY, NJ Job Type: FULL TIME TRAVEL: Must be willing to relocate and work anywhere in the US. Conduct project execution in a global delivery model for delivery of projects using various methodologies (Iterative and AGILE – SCRUM), Partner products, tools & platforms. Deliver...

  • Senior Manager

    1 week ago


    Trenton, United States Marriott Full time

    Job Number 24065201 Job Category Information Technology Location Marriott International HQ, 7750 Wisconsin Avenue, Bethesda, Maryland, United States Schedule Full-Time Located Remotely? Y Relocation? N Position Type Management JOB SUMMARY: The Senior Manager Network Compliance will be responsible for executing a successful network compliance program that...

  • Quality Engineer

    1 week ago


    Trenton, United States LHH Full time

    RESPONSIBILITIES : Participate in daily cross functional interaction and teamwork with Engineering, Operations, Suppliers and Customers Monitor quality control systems to ensure effectiveness and efficiency Collect and analyze production data to evaluate product quality and stop production if serious product defects are present Drive root cause analysis and...

  • Quality Engineer III

    2 weeks ago


    Trenton, United States Integer Holdings Corporation Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success...


  • Trenton, United States New Life Staffing Full time

    Salary: $ 90-110K Hours: Flex schedule can start no earlier than 6 and work no later than 3. Just must put in 40 hour work week. Travel Required: Typically, 2-3 times a month doing a client visit no more than 3 hours from site. Sr level will also have to travel to Kentucky and Virginia once a year. These roles are with the Engineering Team AutoCad experience...

  • Mechanical Engineer

    6 days ago


    Trenton, United States Parette Somjen Architects Full time

    Mechanical Engineer (MEP Design - Quality Control) About us: Parette Somjen Architects (PSA) is a full-service architectural design firm in Morris County, New Jersey. We are a fun and fearless organization with a passion for our work. We provide architectural and design services for commercial, public, and private sector clients across NJ and the tri-state...


  • Trenton, United States New Life Staffing, LLC Full time

    Job DescriptionJob DescriptionSalary: $90-110KHours: Flex schedule can start no earlier than 6 and work no later than 3. Just must put in 40 hour work week. Travel Required: Typically, 2-3 times a month doing a client visit no more than 3 hours from site. Sr level will also have to travel to Kentucky and Virginia once a year. These roles are with the...


  • Trenton, United States New Life Staffing LLC Full time

    Job DescriptionJob DescriptionDescription:Salary: $90-110KHours: Flex schedule can start no earlier than 6 and work no later than 3. Just must put in 40 hour work week.Travel Required: Typically, 2-3 times a month doing a client visit no more than 3 hours from site. Sr level will also have to travel to Kentucky and Virginia once a year.These roles are with...


  • Trenton, United States Micro Manufacturing Solutions for Life Full time

    Senior Quality Engineer - Medical DeviceDo you want to make a difference in the world? Do you want to help save lives? Come start or continue your career with us! MICRO is a contract manufacturer providing services for companies engaged in life-saving products and solutions.MICRO offers an excellent benefits package, compensation higher than industry average...


  • Trenton, United States Micro Manufacturing Solutions for Life Full time

    Senior Quality Engineer - Medical Device Do you want to make a difference in the world? Do you want to help save lives? Come start or continue your career with us! MICRO is a contract manufacturer providing services for companies engaged in life-saving products and solutions. MICRO offers an excellent benefits package, compensation higher than industry...