Medical Device Document Control Specialist

4 days ago


Irvine, California, United States Helpmates Full time
Job Title:

Medical Device Document Control Specialist

About the Job:

We are seeking an experienced Document Control Specialist for an opportunity with our client, a local medical device company. The successful candidate will be responsible for managing documents to ensure compliance with procedures and FDA regulations.

Key Responsibilities:
  • Document Management: Collect, maintain, archive, and retrieve all necessary documents to ensure quality and integrity.
  • Production Monitoring: Monitor production operations to ensure users have the latest accurate revision of documentation.
  • Quality Assurance: Ensure compliance with quality record retention, safeguard information, and retrieve quality records effectively.

The ideal candidate should have extensive experience in document control, quality management, and regulatory requirements such as GMP's and ISO. Strong communication skills and attention to detail are essential.

Requirements:
  • Bachelor's degree in Engineering or scientific discipline or equivalent document control experience.
  • At least 2 years of quality role experience in Medical Device or related industry.
  • Strong understanding of medical device manufacturing processes and regulatory requirements.


  • Irvine, California, United States Aerotek Full time

    Job OverviewAerotek is seeking a skilled Medical Device Assembly Specialist to join our team in Irvine, California. This role offers a unique opportunity for individuals looking to excel in a dynamic and fast-paced industry.The ideal candidate will possess excellent hand-eye coordination and attention to detail, ensuring the production of high-quality...


  • Irvine, California, United States Siella Medical Full time

    We are a Biomedical Repair Facility based in Irvine, CA, seeking a skilled Medical Device Specialist to join our team. This is a full-time position, Monday through Friday.Job Responsibilities:Specialize in the repair of bedside patient monitoring devices at board level and circuitry.Utilize soldering skills and troubleshooting techniques to resolve issues...


  • Irvine, California, United States Aerotek Full time

    Job OverviewAerotek is seeking a skilled Medical Device Production Specialist to join our team in Irvine, California. This is a Contract to Hire position with a competitive salary range of $22.00 - $24.00 per hour.About the JobThis role is responsible for producing high-quality medical devices in a cleanroom environment. The successful candidate will have...


  • Irvine, California, United States Marquee Staffing - OC Full time

    Job Title:Associate Complaint Management Specialist, Medical DeviceAbout the Role:We are seeking a highly organized and detail-oriented individual to join our team as an Associate Complaint Management Specialist. As a key member of our compliance team, you will be responsible for supporting event reporting and investigation procedures related to medical...


  • Irvine, California, United States Aerotek Full time

    Job Title: Medical Device Manufacturing SpecialistWe are seeking a highly skilled Medical Device Manufacturing Specialist to join our team in Irvine, California. This is a contract-to-hire position that offers a competitive salary of $22.00 per hour.About the Job:This role involves working in a manufacturing environment where you will be responsible for...


  • Irvine, California, United States Turion Space Full time

    Job DescriptionTurion Space is seeking a skilled CAD Manager / Document Control Specialist to join our team in Irvine, CA. The successful candidate will be responsible for implementing, maintaining, and training others on the best practices, standards, and operations of the configuration management and CAD toolsets within Turion.Key Responsibilities:* Manage...


  • Irvine, California, United States Kelly Full time

    **Job Title:** Medical Device Project Coordinator SpecialistAt Kelly Services, we're seeking a skilled Medical Device Project Coordinator Specialist to join our team. This role offers an exciting opportunity to contribute to the development of life-saving medical technologies in the electrophysiology catheter and medical device manufacturing space.As a...


  • Irvine, California, United States B. Braun Medical Inc Full time

    Job Summary:B. Braun Medical Inc., a leading manufacturer of infusion therapy and pain management products, is seeking an experienced Quality Control Inspector to join our team in Irvine, CA.As a Quality Control Inspector, you will play a crucial role in ensuring the quality and safety of our medical devices. Your responsibilities will include performing...


  • Irvine, California, United States Aerotek Full time

    We are seeking a Medical Device Assembly Specialist to join our team in Irvine, CA.Job OverviewThis is a fully onsite position that requires the production of high-quality medical devices within a manufacturing cell. The successful candidate will work under close supervision, performing a combination of assembly, repair, and test operations on pacemakers,...


  • Irvine, California, United States Entegee Full time

    Job OverviewWe are seeking a skilled Medical Device Quality Assurance Specialist to join our team. This role will be responsible for investigating product quality issues, performing device testing, and managing complaint investigations in the medical device industry.ResponsibilitiesInvestigate complex product quality and compliance issues from the field;...


  • Irvine, California, United States Aerotek Full time

    Job Description:Aerotek is a leading staffing agency connecting professionals with top employers. We are seeking an experienced Medical Device Production Specialist to join our team in Irvine, California.As a Medical Device Production Specialist, you will be responsible for the production of high-quality medical devices in a cleanroom environment. Your...


  • Irvine, California, United States Aerotek Full time

    Job OpportunityThis position offers a dynamic work environment and opportunities for career advancement as part of a growing company.About the RoleWe are seeking a skilled Medical Device Production Specialist to join our team, responsible for producing high-quality medical devices in a cleanroom environment.The ideal candidate will have experience in the...


  • Irvine, California, United States Marquee Staffing - OC Full time

    Job Overview:">">The Associate Complaint Management Specialist will support the medical device complaint-related procedures by coordinating with internal departments and external authorities.]Schedule: 8:30AM - 5:00PM, Monday to Friday">Estimated Salary: $60,000 - $80,000 per year, based on Southern California market rates">Job Responsibilities:">">Record...


  • Irvine, California, United States Entegee Full time

    Job OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Entegee. In this role, you will be responsible for managing submission publishing, device listings, and UDI data collection in the US and EU markets.The ideal candidate will have 3-4 years of experience in Regulatory Operations within the medical device industry....


  • Irvine, California, United States Aerotek Full time

    About the JobAerotek is seeking a skilled Medical Device Production Specialist to join our team in Irvine, California. This role involves working in a cleanroom environment, where you will be responsible for producing high-quality medical devices.ResponsibilitiesOperate machinery to produce medical devices that meet specifications.Follow manufacturing...


  • Irvine, California, United States Aerotek Full time

    About the RoleWe are seeking an experienced Medical Device Production Specialist to join our team. This role will be responsible for producing high-quality medical devices in a cleanroom environment.ResponsibilitiesFormulate polymers and spray coating formulationsProduce medical devices using microscopesOperate various equipment and...


  • Irvine, California, United States Aerotek Full time

    Job SummaryWe are seeking a skilled Medical Device Production Specialist to join our team in Irvine, California. As an essential member of our production team, you will be responsible for the production of high-quality medical devices in a cleanroom environment.About the RoleThis is a Contract-to-Hire position with a duration of 6 months, offering a...


  • Irvine, California, United States Aerotek Full time

    Job OverviewWe are seeking a highly skilled Medical Device Production Specialist to join our team in Irvine, California. This is a Contract to Hire position with a competitive salary and excellent benefits package.


  • Irvine, California, United States Helpmates Full time

    We are seeking a skilled Medical Device Production Specialist to join our team at Helpmates. In this temporary opportunity, you will work in a local medical device organization assembling and producing quality products.Job Responsibilities:Verify correct components for production.Fully adhere to established procedures and policies.Perform necessary quality...


  • Irvine, California, United States Aerotek Full time

    Job Description:In this role as a Device Production Specialist, you will be responsible for producing high-quality medical devices in a clean room environment. This is a challenging opportunity to utilize your technical skills and attention to detail while working in a dynamic and supportive team environment.Main Responsibilities:Operate machinery to produce...