Senior Quality Assurance Engineer Specialist

5 days ago


Durham, North Carolina, United States Baebies Inc. Full time
Job Title:

Senior Quality Assurance Engineer Specialist

Job Description:

We are seeking a highly experienced and skilled Senior Quality Assurance Engineer to join our team at Baebies Inc. in the medical device industry.

About the Role:

The Senior Quality Assurance Engineer will be responsible for ensuring compliance with FDA, IVDD, IVDR, and ISO 13485 regulations through implementation and maintenance of quality management system design and improvement activities to assure product quality and safety.

Key Responsibilities:
  • Ensure FDA,IVDD, IVDR, ISO 13485 compliance
  • Conduct internal audits and manage external audits
  • Assist in the management of the corrective and preventive action system, initiate, track, close, review and maintain logs and metrics
  • Administration of non-conforming material and deviation processes
  • Support document control administration, including review and routing of change orders, filing records, and training need employee on the use of Unipoint and Arena systems.
  • Pre-Market Quality Assurance (Design and Process Documentation Review)
  • Provide support for equipment and process validation
  • Manage risk management process throughout product life cycle
  • Compile, analyze, trend and present QMS metrics
  • Gather and prepare data for quality meetings and management review meetings
  • Work closely with Regulatory to ensure labeling meets international regulatory requirements
Requirements:
  • 7+ years' experience in Quality Assurance in the medical device industry
  • 5+ years' experience with FDA and ISO 13485 quality systems regulations and guidelines.
  • Performance of Internal audits
  • Product and process related validation
  • Design and development process and DHF requirements
  • Software validation activities for medical devices
  • Experience in small to medium size medical company is preferred.
Qualifications:
  • BS in engineering or life science field.
Salary:

$100,000 per year, estimated based on market trends and industry standards.

Baebies Inc. Offers:

A dynamic and welcoming work environment surrounded by intelligent, driven, and creative people.

We provide a comprehensive employee benefits package including:

• 100% employee premiums for Medical & Vision coverage

• 100% employee and family premiums for Dental coverage

• 401K available

• Stock Options

• 4 Weeks PTO

• 14 Paid Holidays per year

• Paid Employee Life Insurance

• Onsite free gym membership & classes

• Discount Pet & Legal Insurance

• Fertility & Family Support

• Much more



  • Durham, North Carolina, United States Integrated Resources, Inc Full time

    Integrated Resources, Inc. is seeking an experienced Senior Quality Assurance Specialist to join our team in Durham, NC.About the RoleThis position will be responsible for environmental monitoring in aseptic environments, collection and processing of water samples, component, and product release testing. The ideal candidate must have strong interpersonal,...


  • Durham, North Carolina, United States Lilly Full time

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lilly in Raleigh-Durham, North Carolina. As a member of our Quality Assurance department, you will play a critical role in ensuring the quality and safety of our parenteral and device products.About the RoleThe Senior Quality Assurance Specialist will be responsible for...


  • Durham, North Carolina, United States Cambrex High Point Full time

    Job SummaryCambrex High Point is seeking a highly skilled Quality Assurance Specialist II to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Perform independent quality evaluations and releases of support documentation, materials, products,...


  • Durham, North Carolina, United States U.S. Engineering Full time

    We are seeking an experienced Senior Quality Assurance Manager to join our team at U.S. Engineering.Job SummaryThis is a challenging opportunity for a seasoned professional with a strong background in quality assurance and control to lead our quality management initiatives.About the RoleThe successful candidate will be responsible for planning, directing,...


  • Durham, North Carolina, United States Tempus Full time

    About the RoleTempus is seeking a Senior Supplier Quality Assurance Specialist to play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations.This individual will also support various QMS activities that comply...


  • Durham, North Carolina, United States MILLENNIUMSOFT Full time

    Job Title: Staff Quality Engineer Location: Durham, NC Duration: 9+ Months Contract Total Hours/week: 40.00 The Millenniumsoft company is seeking a highly skilled Staff Quality Engineer to support the Quality team at our Durham, NC R&D facility. The successful candidate will ensure that design history files (DHF) for identified products meet all corporate...


  • Durham, North Carolina, United States Fidelity TalentSource LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Data Engineer and QA Automation Specialist to join our Workplace Investing Quality Engineering team at Fidelity TalentSource LLC.About the RoleThis exciting new role within the Workplace Investing (WI) Data Engineering space requires a senior-level professional with expertise in designing, developing, and...


  • Durham, North Carolina, United States PEAK Technical Staffing USA Full time

    Job DescriptionAt PEAK Technical Staffing USA, we are seeking a highly skilled Quality Assurance Specialist to join our team. This is a full-time position with a competitive salary of $16-$17/hour.The ideal candidate will have a strong attention to detail and be able to read instructions to understand quality expectations for products and raw materials.**Key...


  • Durham, North Carolina, United States Actalent Full time

    Job Description:We are looking for a highly skilled Quality Assurance Engineer to join our software test development team. The ideal candidate will have experience in designing and developing test cases, automating test scripts, and working closely with development teams.Key Responsibilities:Design and develop test cases to verify software applications...


  • Durham, North Carolina, United States Piper Companies Full time

    Piper Companies is a leading pharmaceutical company based in Durham, North Carolina. We are currently seeking a Biopharmaceutical Quality Assurance Specialist to join our team.


  • Durham, North Carolina, United States NetApp Full time

    We are seeking a skilled Software Quality Assurance Engineer to join our team at NetApp.Company OverviewNetApp is a leader in data management solutions, helping customers turn challenges into business opportunities. Our innovative approach combines fresh thinking with proven expertise to deliver exceptional results.Job SummaryThis role involves working...


  • Durham, North Carolina, United States NavitsPartners Full time

    Job DescriptionAt NavitsPartners, we are seeking a highly skilled Quality Assurance Specialist to support our validation activities throughout the product lifecycle. As a key member of our team, you will be responsible for providing validation support for equipment calibration documentation and ensuring compliance with corporate and industry standards.The...


  • Durham, North Carolina, United States Piper Companies Full time

    Job OpportunityPiper Companies is a leading pharmaceutical company based in Durham, North Carolina.We are currently seeking a Biopharmaceutical Quality Assurance Specialist to join our team. The ideal candidate will be responsible for conducting quality walk-throughs of production, testing and warehouse locations, collecting samples for carbon, surface and...


  • Durham, North Carolina, United States PEAK Technical Staffing USA Full time

    Job Description:We are seeking a Quality Assurance Specialist to join our team at PEAK Technical Staffing USA in Durham, NC.About the Job:This is a full-time position that offers a competitive salary of $16-$17 per hour.Key Responsibilities:Ensure quality standards are met by reading instructions and approving or rejecting raw materials.Select material...


  • Durham, North Carolina, United States TalentBurst Full time

    We are seeking a highly detail-oriented Production Quality Assurance Specialist to join our team at TalentBurst in Durham, NC. As a key member of our production team, you will be responsible for ensuring the quality and integrity of our products from start to finish.About the RoleThe ideal candidate will have at least 1 year of experience within a...


  • Durham, North Carolina, United States Insight Global Full time

    Seeking an Environmental Monitoring and Quality Assurance Specialist to join Insight Global. This role is perfect for individuals who are passionate about environmental monitoring and quality assurance.About the Role:We are looking for a highly skilled and detail-oriented individual to perform sampling of air for viable and non-viable particle counts along...


  • Durham, North Carolina, United States PowerSecure, Inc. Full time

    Job DescriptionThe Senior Electrical Engineering Support Specialist will be responsible for providing technical support to customers on PowerSecure MicroGrid equipment, including switchgear and generators. This role requires a strong understanding of electrical engineering principles and experience working with commercial/industrial power generation...


  • Durham, North Carolina, United States Cypress HCM Full time

    Job Title:Senior Molecular Diagnostics SpecialistAbout Cypress HCMCypress HCM is a leading healthcare organization dedicated to delivering exceptional patient care and innovative medical services.Salary InformationWe offer an attractive salary range of $180,000 - $220,000 per annum, commensurate with experience.Job DescriptionMolecular Pathologist Role...


  • Durham, North Carolina, United States KBI BioPharma Full time

    About UsKBI BioPharma is a leading biopharmaceutical company that strives to deliver high-quality products and services.Job DescriptionWe are seeking an experienced Deviation Specialist to join our team. The successful candidate will be responsible for ensuring the timely review and approval of Deviations, CAPAs and ECs, in accordance with cGMP requirements...


  • Durham, North Carolina, United States MMR Consulting Full time

    Estimated salary range: $120,000 - $180,000 per year.About MMR Consulting:MMR Consulting is a leading engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. With expertise in Engineering, Project Management, and other Consulting services, our team provides comprehensive solutions to clients worldwide.Job...