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Costa Rica Medical Device Quality Jobs in Michigan

... medical device components under controlled conditions. You wear personal protective equipment, including eyewear, ear plugs, a hair net, and protective gowning, to maintain product quality and safety.

Quality Engineer, Service

Kalamazoo, MI · On-site

$69K - $110K/yr

Experience in medical device development, manufacturing, servicing, or another regulated industry environment * Knowledge of FDA regulations, ISO standards, and applicable quality system requirements

Quality Engineer, Service

Kalamazoo, MI · On-site

$69K - $110K/yr

Experience in medical device development, manufacturing, servicing, or another regulated industry environment * Knowledge of FDA regulations, ISO standards, and applicable quality system requirements

CNC Turning Operator

Holland, MI · On-site

$21 - $25/hr

Strong attention to detail and commitment to quality * Comfortable working in a regulated manufacturing environment Preferred (Not Required) * Medical device manufacturing experience * CNC ...

Experience supporting complex assemblies, precision components, optics, semiconductor, medical device, aerospace, or other high-technology manufacturing environments. * ASQ Certified Quality Engineer ...

Experience supporting complex assemblies, precision components, optics, semiconductor, medical device, aerospace, or other high-technology manufacturing environments. * ASQ Certified Quality Engineer ...

Experience supporting complex assemblies, precision components, optics, semiconductor, medical device, aerospace, or other high-technology manufacturing environments. * ASQ Certified Quality Engineer ...

Responsible for maintaining quality-assurance processes, measuring & testing products, and ... medical device, etc.) a plus. * Attention to detail and an aptitude for working with data are ...

Experience supporting complex assemblies, precision components, optics, semiconductor, medical device, aerospace, or other high-technology manufacturing environments. * ASQ Certified Quality Engineer ...

Be Seen First

We support leading medical device manufacturers with precise, compliant warehouse operations ... Maintain a clean, organized, and safe warehouse environment in line with quality system ...

Models clinical safety and quality first mindset * Takes initiative and proactively mitigates risks * Continuous education focused to advance job knowledge in medical device design & development

Showing results 41-60

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:

Associate Manager, Quality Engineering

Stryker

Portage, MI • On-site

$110K - $183K/yr

Full-time

Posted 14 days ago


Key responsibilities

  • Oversee quality programs, including complaint handling, post-market surveillance, and quality system processes.

  • Lead and develop a team of Quality Engineers and Technicians to achieve quality, compliance, and operational objectives.

  • Partner with cross-functional teams to investigate, resolve, and communicate customer-impacting quality issues.


Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

134th of 499 rated machine equipment manufacturers


Job description

Work Flexibility: Hybrid
Join Stryker's Emergency Care business as an Associate Manager, Quality Engineering in Portage, MI supporting global complaint handling and post-market surveillance activities. In this leadership role, you will oversee quality programs, lead a team of Quality Engineers and Technicians, and partner across functions to ensure product quality, regulatory compliance, and continuous improvement. This position offers the opportunity to influence quality strategy, operational performance, and team development within a highly regulated medical device environment.
Workplace Flexibility: Candidate must reside within a commutable distance to Portage, MI which will be expected to be onsite at the facility Monday through Wednesday with optional remote days on Thursday and Friday depending on business needs.
What You Will Do
  • Own talent strategy including hiring, workforce planning, performance management, and succession planning.
  • Lead and develop a team of Quality Engineers and Technicians to achieve quality, compliance, and operational objectives.
  • Represents Stryker in customer-facing quality discussions, partnering with sales and field teams to investigate concerns, communicate outcomes, and maintain customer trust.
  • Establish and monitor key performance indicators (KPIs), quality objectives, and departmental goals.
  • Partner with cross-functional teams to investigate, resolve, and communicate customer-impacting quality issues.
  • Analyze complaint, warranty, and product quality data to identify trends, emerging risks, and improvement opportunities.
  • Lead the development and implementation of complaint handling, post-market surveillance, and quality system processes.
  • Support internal and external audits and ensure compliance with applicable regulatory requirements and quality standards.
  • Manage departmental budgets and warranty-related costs while driving continuous improvement initiatives.

What You Will Need
Required Qualifications
  • Bachelor's degree required. Bachelor's degree in engineering, science, or a related technical field strongly preferred.
  • Minimum 6 years of experience in Quality Assurance, Research & Development, Regulatory Affairs, Service, or Operations within a regulated industry.

Preferred Qualifications
  • Experience leading or managing technical teams, including employee development and performance management.
  • Experience supporting compliance with U.S. and international medical device regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Experience leading process improvement, complaint handling, or post-market quality initiatives.

USN: $110,100 - $183,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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