Medical Quality Assurance Specialist

2 days ago


Brooklyn Park, Minnesota, United States Cirtec Medical Full time
About Us

Cirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. Our expertise spans active implants, neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Job Description

This role will ensure operational adherence to Cirtec Medical's Quality Management System (QMS) requirements. The ideal candidate will provide input on quality system improvement strategies and approaches.

Key Responsibilities
  • Corrective/Preventive Actions: Responsible for CAPA administration, tracking individual CAPAs, and performing work on individual CAPAs as necessary.
  • Supplier Quality Management: Support Qualification activities and maintenance of the Approved Supplier List (ASL). Support management of Supplier/vendor Corrective Actions (SCAR).
  • Internal Auditing: Ensure all internal audits are performed as scheduled. Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System.
Required Skills and Qualifications
  • Bachelor's Degree required with 0 years of experience, or a combination of education and relevant work experience.
  • Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
Estimated Salary: $70,000 - $90,000 per year

  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    About Cretex Medical Component and Device TechnologiesCretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in areas such as injection molding, laser processing, metal stamping, and device assembly. Learn more at our official website.Salary:$85,000...


  • Brooklyn Park, Minnesota, United States Randstad USA Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Randstad USA. This is a direct hire position, and we require candidates with automotive manufacturing experience to apply.This role involves 100% inspection, as well as interpreting customer contracts and purchase orders to ensure compliance. Inspections may...


  • Brooklyn Park, Minnesota, United States Cirtec Medical Full time

    About UsCirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. With over three decades of experience, we specialize in providing comprehensive services from design and development to manufacturing and finished device assembly.Job DescriptionThe Quality Systems Engineer will be responsible for ensuring...


  • Brook Park, Minnesota, United States Diversified Machine Components LLC Full time

    Job SummaryWe are seeking a skilled Technical Quality Assurance Specialist to join our team at Diversified Machine Components LLC. This role will focus on ensuring the highest quality products and services in various industries.


  • Brook Park, Minnesota, United States Nesco Resource Full time

    Overview:Nesco Resource is a leading provider of staffing services, and we are currently seeking a highly skilled Senior Quality Assurance Specialist to join our team.About the Role:This 2nd shift position is responsible for ensuring the quality of our products meets strict standards and complies with food safety regulations.Key Responsibilities:Inspecting...


  • Brooklyn Park, Minnesota, United States Cirtec Medical Full time

    Cirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. We're seeking a talented Quality Engineer II to join our team and help us deliver high-quality products to our customers.About the JobIn this role, you'll be responsible for providing Quality Engineering support for engineering project development or...


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Company OverviewCretex Medical Component and Device Technologies is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly.


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    About Cretex Medical We recognize the contribution of every individual and promote growth, safety, and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. 'The culture at Cretex is collaborative. Everyone...


  • Brooklyn Park, Minnesota, United States Velosity Full time

    Company OverviewVelosity is a cutting-edge medical parts manufacturer that enhances speed and cuts costs by engineering efficient processes.


  • Brooklyn Park, Minnesota, United States Allina Health Full time

    Becoming a Medical Care Specialist at Allina HealthAbout the RoleWe are seeking a skilled Medical Care Specialist to join our team in Orthopedic Surgery. As a Medical Care Specialist, you will provide high-quality patient care, working closely with our Physician/Physician Assistant team to deliver exceptional outcomes.Key ResponsibilitiesProviding Clinical...


  • Brooklyn Park, Minnesota, United States Cirtec Medical Full time

    Our TeamCirtec Medical is committed to creating a culture that values innovation, respect, transparency, and communication. We believe that our employees are the key to our success.Job DescriptionThe Compliance and Quality Engineer will be responsible for ensuring operational adherence to Cirtec Medical's Quality Management System (QMS) requirements.Key...


  • Brooklyn Park, Minnesota, United States Cirtec Medical Full time

    About Our CompanyCirtec Medical has been a leading provider of manufacturing solutions for over three decades. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly.Job SummaryWe are seeking a Compliance and Quality Engineer to join our team. This role will be responsible for ensuring...


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Benefits OverviewCretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision, and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay. Cretex Medical also offers company-specific...


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    **Job Summary:** We are seeking an experienced Manufacturing Operations Specialist to join our team at Cretex Medical Component and Device Technologies. This is a full-time position that requires strong technical skills and attention to detail.The successful candidate will be responsible for operating and tending equipment to create medical device parts,...


  • Brooklyn Park, Minnesota, United States Three Point Solutions Full time

    Job Title: Medical Device Assembler Specialist - 1st Shift ($20/hr)\This is a highly rewarding role that involves assembling medical devices on multiple product lines. The ideal candidate will have a strong background in assembly operations and be able to meet or exceed quality standards.Responsibilities:\\Demonstrate proficiency in tasks associated with...


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Cretex Medical Component and Device TechnologiesOverviewWe are a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly.About UsCretex Medical Component and Device Technologies is...


  • Brooklyn Park, Minnesota, United States Three Point Solutions Full time

    Job SummaryWe are looking for an experienced Medical Device Production Specialist to join our team. In this role, you will be responsible for assembling medical devices and maintaining a clean, safe workspace.You will need to have a strong understanding of Good Documentation Practices, Good Manufacturing Practices, and Lean Manufacturing principles....


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    About the RoleThe Assembly Operations Specialist will be responsible for operating and maintaining manufacturing equipment to produce high-quality products. The ideal candidate will have experience in a cleanroom environment and be able to work effectively in a team.


  • Brooklyn Park, Minnesota, United States Takeda Pharmaceutical Company Ltd Full time

    About the Role:Become part of a dynamic team at Takeda Pharmaceutical Company Ltd where you will be responsible for independently building and reviewing routine in-process, drug substance, and stability test methods promptly.Utilize a variety of laboratory instrumentation and computer systems to collect and record data, including LIMS, SoftmaxPro, Charles...


  • Brooklyn Park, Minnesota, United States Cretex Medical Component and Device Technologies Full time

    Job Overview: We are seeking an experienced Product Launch Specialist to join our team at Cretex Medical Component and Device Technologies. In this role, you will be responsible for validating, designing, developing, and training to manufacturing processes while working through a defined stage gate process. You will also provide direction and support for...