Sr. Quality Compliance Engineer

Found in: Talent US C2 - 2 weeks ago

Elkton, United States TMC Compliance 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

  • Sr. Quality Compliance Engineer

    Found in: Talent US C2 - 7 days ago

    Elkton, 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...

  • Sr Quality Compliance Engineer

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job SummaryThe 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...

  • Sr Quality Compliance Engineer

    Found in: Appcast US C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job SummaryThe 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...

  • Quality Specialist

    Found in: Appcast Linkedin GBL C2 - 7 days ago

    Elkton, United States Astrix Full time

    Our esteemed client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an exceptional Quality Specialist to join their dynamic team.ResponsibilitiesCollaborate with...

  • Quality Specialist

    Found in: Appcast US C2 - 7 days ago

    Elkton, United States Astrix Full time

    Our esteemed client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an exceptional Quality Specialist to join their dynamic team.ResponsibilitiesCollaborate with...

  • Quality Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Elkton, United States TALENT Software Services Full time

    Are you an experienced Quality Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Quality Specialist to work in Elkton, VA.Position Summary: At the client's campus in Elkton, Virginia, we have a Specialist Quality Assurance position available on our Quality Team. The...

  • Quality Specialist

    Found in: Appcast US C2 - 2 weeks ago

    Elkton, United States TALENT Software Services Full time

    Are you an experienced Quality Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Quality Specialist to work in Elkton, VA.Position Summary: At the client's campus in Elkton, Virginia, we have a Specialist Quality Assurance position available on our Quality Team. The...

  • Specialist – Quality Assurance

    Found in: Appcast US C2 - 7 days ago

    Elkton, United States Pacer Staffing Full time

    Title: Quality Specialist - I (Assistant) Location: Elkton, VA 22827 Duration: 8 months Shift Hours: Monday to Friday, Standard time. Summary: If you are the kind of individual who thrives on challenges and possesses the quality, compliance, leadership, business, and communication skills that are of value to our business, we invite...

  • Quality Specialist

    1 week ago

    Elkton, United States Collabera Full time

    Job DescriptionJob DescriptionResponsibilities:The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.The role will support the review and approval of qualification activities,...

  • Sustaining Engineer

    1 week ago

    Elkton, United States CareerBuilder Full time

    Job Summary: This position is responsible for investigating, leading, planning, developing and implementing the more complex product design change projects in support of existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Job Details: Maintain and follow TMC Quality System...

  • Sustaining Engineer

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary:This position is responsible for investigating, leading, planning, developing and implementing the more complex product design change projects in support of existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Job Details:Maintain and follow TMC Quality System...

  • Sustaining Engineer

    2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary:This position is responsible for investigating, leading, planning, developing and implementing the more complex product design change projects in support of existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Job Details:Maintain and follow TMC Quality System...

  • Sustaining Engineer

    Found in: Appcast US C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary:This position is responsible for investigating, leading, planning, developing and implementing the more complex product design change projects in support of existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Job Details:Maintain and follow TMC Quality System...

  • Sr. Manager, TMC Manufacturing Applications

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    The Sr Manager, Manufacturing IT will lead the global manufacturing technology strategy, tactical planning and develop and direct the operation of manufacturing IT systems. The incumbent will ensure that the operational technology portfolio enhances organizational strategy and global information management through successful, consistent, and predictable...

  • Sr. Manager, TMC Manufacturing Applications

    Found in: Appcast US C2 - 7 days ago

    Elkton, United States Terumo Medical Corporation Full time

    The Sr Manager, Manufacturing IT will lead the global manufacturing technology strategy, tactical planning and develop and direct the operation of manufacturing IT systems. The incumbent will ensure that the operational technology portfolio enhances organizational strategy and global information management through successful, consistent, and predictable...

  • Sr. Injection Molding

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary: This position is responsible for the investigation, development, and implementation of new injection molding and/ or extrusion processes and technology. This person would be considered the subject matter expert in their field and must possess a thorough understanding of their engineering discipline. It is expected that the Senior Engineer II...

  • Sr. Injection Molding

    Found in: Appcast US C2 - 2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary: This position is responsible for the investigation, development, and implementation of new injection molding and/ or extrusion processes and technology. This person would be considered the subject matter expert in their field and must possess a thorough understanding of their engineering discipline. It is expected that the Senior Engineer II...

  • Quality Assurance Specialist

    1 week ago

    Elkton, United States Net2Source Inc. Full time

    Title: Quality Specialist - I (Assistant) Duration: 12 months Location: Elkton, VA Job Description: The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations. The role will support...

  • Quality Specialist

    1 week ago

    Elkton, United States Merck Full time

    Job DescriptionJob Description Qualifications:Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: Previous experience supporting aseptic...

  • Quality Specialist

    Found in: Talent US C2 - 1 week ago

    Elkton, United States TalentBurst, Inc. Full time

    Title: Quality SpecialistLocation: Elkton, VADuration: 12+ monthsJob Description:The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations. The role will support the review and...