ZipRecruiter

Log In

1

Costa Rica Medical Device Quality Jobs in Indiana

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Software Quality Engineer Warsaw, IN Hybrid role (3 days in office) $55 - $64 per hour ABOUT THE ... Support the design, development, and testing of medical device software, including Software as a ...

Hearst UK

Medical Coder Specialist

Indianapolis, IN · On-site

Medical Device In The Quality Department In Some Jobs You Take Orders. In This One, You Write History. Join the healthcare information technology team that's turning drug and medical device data into ...

Hearst Health

Medical Coder Specialist

Indianapolis, IN · On-site

Medical Device In The Quality Department Join the healthcare information technology team that's turning drug and medical device data into knowledge used by thousands of hospitals; the majority of U.S ...

CTE Solutions

Senior Quality Engineer

Plymouth, IN · On-site

$80K - $109K/yr

Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Reviewing and ... Strong background in quality control and quality engineering functions * Understanding GD&T

Hearst

Medical Coder Specialist

Indianapolis, IN · On-site

Medical Device In The Quality Department Join the healthcare information technology team that's turning drug and medical device data into knowledge used by thousands of hospitals; the majority of U.S ...

BSI Prof Serv EHS West

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

BSI Group

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

OrthoPediatrics

Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

... of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971) EDUCATION AND/OR EXPERIENCE: Requires a Bachelor degree in Industrial Engineering, Industrial ...

Hearst

Medical Coder Specialist

Carmel, IN · On-site

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

Hearst Health

Medical Coder Specialist

Carmel, IN · On-site

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

avalign

Sr. Design Quality Engineer

Fort Wayne, IN

The Design Quality Engineer will be responsible for the quality and regulatory related activities ... Support processes for Medical Device Reporting and Complaints for Avalign as specification ...

Hearst

Medical Coder Specialist

Carmel, IN

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

Hearst

Medical Coder Specialist

Carmel, IN · On-site

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

previous pagenext page

Showing results 21-40

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

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 Indiana?

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

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

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

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

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

Costa Rica Medical Device Quality jobs near you
Infographic showing various Costa Rica Medical Device Quality job openings in Indiana as of June 2026, with employment types broken down into 5% Full Time, 66% Part Time, 27% Temporary, and 2% Nights. Highlights an 96% Physical, 2% Hybrid, and 2% Remote job distribution.

Software Quality Engineer

Brooksource

Indianapolis, IN • On-site

$55 - $64/hr

Contractor

Medical, Dental, Vision, Retirement, PTO

Posted 28 days ago

Job description

Software Quality Engineer
Warsaw, IN
Hybrid role (3 days in office)
$55 - $64 per hour
ABOUT THE ROLE
Join a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle-from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.
WHAT YOU'LL DO
  • Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products
  • Provide leadership, guidance, and expertise on software development processes, procedures, and practices
  • Serve as a subject matter expert in requirements gathering, test strategy definition, and design controls
  • Facilitate documentation and tracking of verification activities, including code review findings
  • Review test case execution results and manage software defects
  • Facilitate software risk assessment sessions and own the development of risk documentation
  • Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation
  • Provide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topics
  • Conduct training on medical device software development processes and quality systems; develop associated work instructions
  • Provide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirements

WHAT YOU BRING
  • Bachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)
  • Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineering
  • Experience in the medical device industry
  • Proficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)
  • Strong interpersonal, organizational, and verbal/written communication skills
  • Ability to work collaboratively in a team environment and demonstrate leadership
  • Ability to perform duties in accordance with company policies, procedures, and civil rights requirements
  • ASQ Certification as a Software Quality Engineer or equivalent (preferred)
  • Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)
  • Ability to facilitate software risk assessments and develop risk documentation

WHAT'S IN IT FOR YOU
  • Opportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences company
  • Exposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvement
  • Meaningful mentorship scope and cross-collaborative team and business partners
  • Hybrid work environment (3 days in office)

Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks:
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Apply