ZipRecruiter

Log In

1

Costa Rica Medical Device Quality Jobs in Michigan

Omnex Inc

Omnex Consultant ISO 13485

Ann Arbor, MI · On-site

$80 - $100/hr

... Medical Device Sector: Quality Professionals with extensive hands-on experience in the following: * Quality Management Systems (ISO 13485, 21 CFR 820) * Regulatory Standards * Other parts of the US ...

Posted today

Medtronic

Sr Packaging Engineer

Dexter, MI · On-site

Working knowledge of ISO 11607, ISO 13485, Design Control requirements, and medical device quality system processes. * Experience with sterilization methods, sterile barrier systems, biomedical ...

Medtronic

Sr Packaging Engineer

Dexter, MI · On-site

Working knowledge of ISO 11607, ISO 13485, Design Control requirements, and medical device quality system processes. * Experience with sterilization methods, sterile barrier systems, biomedical ...

New

Manpower

Medical Equipment Technician

Grand Rapids, MI · On-site

$19/hr

Medical Device Repair Technician Location: Grand Rapids, MI Pay: $19.00/hour Schedule: Monday ... Follow quality and safety standards. Qualifications * High school diploma or GED. * Strong ...

Medtronic

Sr Packaging Engineer

Dexter, MI

Working knowledge of ISO 11607, ISO 13485, Design Control requirements, and medical device quality system processes. * Experience with sterilization methods, sterile barrier systems, biomedical ...

New

Emerson

Finance Supervisor

Novi, MI · On-site

Minimal travel to Mexico or Costa Rica may be required * Authorized to work in the United States ... We provide a variety of medical insurance plans, with dental and vision coverage, Employee ...

Emerson Group

Finance Supervisor

Novi, MI · On-site

Minimal travel to Mexico or Costa Rica may be required * Authorized to work in the United States ... We provide a variety of medical insurance plans, with dental and vision coverage, Employee ...

City of Shakopee, MN

Finance Supervisor

Novi, MI · On-site

$100 - $125/hr

Minimal travel to Mexico or Costa Rica may be required * Authorized to work in the United States ... We provide a variety of medical insurance plans, with dental and vision coverage, Employee ...

Aptiv PLC

Senior Payroll Analyst

Troy, MI · On-site

Wind River helps customers across automotive, aerospace, defense, industrial, medical, and ... regions (Costa Rica, U.S., and Canada), ensuring accuracy, compliance, and efficiency. You'll ...

Aptiv

Senior Payroll Analyst

Troy, MI · On-site

Wind River helps customers across automotive, aerospace, defense, industrial, medical, and ... regions (Costa Rica, U.S., and Canada), ensuring accuracy, compliance, and efficiency. You'll ...

Stryker

Staff Advanced Quality Engineer

Portage, MI · On-site

$89K - $148K/yr

Hybrid Staff Advanced Quality Engineer Portage, MI Join a team focused on advancing quality throughout the product development lifecycle in a regulated medical device environment. As a Staff Advanced ...

previous pagenext page

Showing results 21-40

All JobsCosta Rica Medical Device Quality JobsCosta Rica Medical Device Quality Jobs in Michigan

Costa Rica Medical Device Quality information

What is a Costa Rica medical device quality job?

Costa Rica Medical Device Quality jobs involve ensuring that medical devices manufactured or distributed in Costa Rica meet local and international quality standards and regulatory requirements. Professionals in these roles oversee quality assurance processes, conduct audits, manage compliance documentation, and collaborate with engineering and production teams to maintain product safety and effectiveness. These positions are crucial in the country's growing medical device sector, which is known for its adherence to strict quality and regulatory standards.

What are the key skills and qualifications needed to thrive in medical device quality roles in Costa Rica?

To thrive in a Medical Device Quality role in Costa Rica, you need a solid understanding of quality management systems, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and experience in medical device manufacturing. Familiarity with quality assurance tools, document control systems, and certifications like Six Sigma or ASQ Certified Quality Engineer are typically required. Strong attention to detail, analytical thinking, and effective teamwork and communication skills help individuals excel in this field. These competencies ensure products meet rigorous safety and regulatory standards, supporting both patient safety and company reputation.

What are common challenges faced by professionals working in medical device quality roles in Costa Rica, and how can they be addressed?

Professionals in medical device quality roles in Costa Rica often face challenges related to navigating both local and international regulatory requirements, ensuring consistent product quality, and adapting to frequent updates in compliance standards. Effective communication and collaboration with cross-functional teams—such as engineering, production, and regulatory affairs—are crucial for addressing these challenges. Staying updated with global quality standards, participating in regular training, and utilizing robust quality management systems can help professionals maintain compliance and drive continuous improvement.

What is the difference between Costa Rica Medical Device Quality vs Costa Rica Medical Device Regulatory Affairs Specialist?

AspectCosta Rica Medical Device QualityCosta Rica Medical Device Regulatory Affairs Specialist
CertificationsISO 13485, internal quality auditsRegulatory compliance, local and international approvals
Work EnvironmentManufacturing sites, quality control labsRegulatory agencies, documentation review
Industry UsageQuality assurance, process improvementRegulatory submissions, compliance management

While both roles focus on ensuring medical device safety and compliance, Costa Rica Medical Device Quality primarily emphasizes quality assurance and process control within manufacturing. In contrast, Costa Rica Medical Device Regulatory Affairs Specialists handle regulatory submissions and ensure compliance with local and international regulations. Both roles are essential in the medical device industry but differ in their core responsibilities and daily tasks.

What are popular job titles related to Costa Rica Medical Device Quality jobs in Michigan?

For Costa Rica Medical Device Quality jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Costa Rica Medical Device Quality jobs in Michigan look for?

The top searched job categories for Costa Rica Medical Device Quality jobs in Michigan are:

What cities in Michigan are hiring for Costa Rica Medical Device Quality jobs?

Cities in Michigan with the most Costa Rica Medical Device Quality job openings:

Costa Rica Medical Device Quality jobs near you

Omnex Consultant ISO 13485

Omnex Inc

Ann Arbor, MI • On-site

$80 - $100/hr

Other

Posted 21 hours ago

Posted today

Job description

Omnex, Inc., a global consulting, training and software development company (www.omnex.com) based in Ann Arbor, MI, has significant opportunities for highly qualified consultants to help with efforts in the Medical Device Sector:

Quality Professionals with extensive hands-on experience in the following:

  • Quality Management Systems (ISO 13485, 21 CFR 820)
  • Regulatory Standards
  • Other parts of the US 21 CFR dealing with Medical Devices (i.e., parts 4, 11, 50, 99, 800, 801, 803, 806, 807, 808, 810, 812, 814, 820, and etc.)
  • MDR (EU 2017/745, 746)
  • MDSAP
  • Risk Management (ISO 14971 & ISO 24971)
  • SaMD (Software as a Medical Device), & SiMD (Software in a Medical Device)
  • IEC ISO 62304
  • FDA Guidance
  • IMDRF Guidance
  • Cybersecurity Guidance
  • Core Tools (APQP, FMEA, MSA, SPC, & PPAP)

Auditor background and experience would be a plus. Also, a good working knowledge of other ISO Management systems & standards would be a plus. Self-starter with minimum 1-5 years’ experience in the Medical Device Industry would be preferred, along with a Bachelor’s Degree.

#J-18808-Ljbffr

Apply