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Costa Rica Medical Device Quality Jobs (NOW HIRING)

Anonymous Employer

Med-Device Assembler

Providence, RI

$21 - $23/hr

**Job Title: **Med-Device Assembler (x2) **Pay Rate: **$21-$23/hr. ($21/hr. without soldering $23/hr ... Maintain a clean and organized work area to ensure safety and device quality * Escalate issues and ...

Viant

Process Engineer

San Antonio, TX · On-site

S., Costa Rica, Tijuana, and Vega Baja, PR) Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life ...

FreeBalance

Project Manager (Costa Rica)

Houston, TX · On-site

... quality deliverables and maintaining the projects responsibility matrix * Support with updating ... Knowledge of HRM/Payroll System in the public sector, particularly in Costa Rica, is an asset.

FreeBalance

Project Director (Costa Rica)

Miami, FL · On-site

... quality deliverables and maintaining the projects responsibility matrix * Support with updating ... Knowledge of HRM/Payroll System in the public sector, particularly in Costa Rica, is an asset.

FreeBalance

Project Director (Costa Rica)

Miami, FL

... quality deliverables and maintaining the projects responsibility matrix * Support with updating ... Knowledge of HRM/Payroll System in the public sector, particularly in Costa Rica, is an asset.

FreeBalance

Project Director (Costa Rica)

Miami, FL

... quality deliverables and maintaining the projects responsibility matrix * Support with updating ... Knowledge of HRM/Payroll System in the public sector, particularly in Costa Rica, is an asset.

ATL Technology

Quality Engineer II/III

Maple Grove, MN · On-site

$73K - $95K/yr

Quality Engineer II/III The Quality Engineer with have a great aptitude for learning, being ... top medical device manufacturers. ATL has operations in China, Costa Rica, Taiwan, UT-USA, plus ...

ATL Technology

Quality Engineer II/III

Maple Grove, MN

$73K - $95K/yr

Quality Engineer II/III The Quality Engineer with have a great aptitude for learning, being ... top medical device manufacturers. ATL has operations in China, Costa Rica, Taiwan, UT-USA, plus ...

Saxon Global

QA ENGINEER

Saint Augustine, FL

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

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Costa Rica Medical Device Quality information

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$21

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$70

How much do costa rica medical device quality jobs pay per hour?

As of Jun 30, 2026, the average hourly pay for costa rica medical device quality in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Medical Device Quality roles in Costa Rica, and why are they important?

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 some 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 Costa Rica Medical Device Quality jobs?

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.
More about Costa Rica Medical Device Quality jobs
What cities are hiring for Costa Rica Medical Device Quality jobs? Cities with the most Costa Rica Medical Device Quality job openings:
What states have the most Costa Rica Medical Device Quality jobs? States with the most job openings for Costa Rica Medical Device Quality jobs include:
What job categories do people searching Costa Rica Medical Device Quality jobs look for? The top searched job categories for Costa Rica Medical Device Quality jobs are:
Costa Rica Medical Device Quality jobs near you
Infographic showing various Costa Rica Medical Device Quality job openings in the United States as of June 2026, with employment types broken down into 4% Full Time, 67% Part Time, 27% Temporary, and 2% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.
Sr. Engineer, Combination Products & Medical Device

Sr. Engineer, Combination Products & Medical Device

Hikma Pharmaceuticals PLC

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 23 days ago

Key responsibilities

  • Develop and ensure lifecycle management of a Quality Management System compliant with relevant combination product and medical device regulations.

  • Assess, evaluate, identify, and implement required documentation and studies to support requirements for launch, lifecycle changes, and business development opportunities.

  • Lead and participate on departmental and cross-functional teams as a subject matter expert in combination products and medical devices.

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

37th of 73 rated pharmaceutical

Job description

Job Title: Sr. Engineer, Combination Products & Medical Device
Location: Columbus, OH
Job Type: Full time
Req ID: 11621
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Engineer, Combination Products & Medical Device to join our team.
In this role, you will be responsible for providing Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization.
Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.
Responsibility also includes assessing, evaluating, identifying and implementing required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities to meet identified business objectives and targets.
Key Responsibilities:
Knowledge Management
  • Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities' expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO14971, etc...
  • Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
  • Active member of relevant industry groups and key stakeholder organizations
  • Direct the work of consultants as needed and mentor others
  • Responsible for driving site education with regards to combination products and medical device requirements and organizational processes.

Infrastructure Support
  • Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations
  • Work within a Center of Excellence to share and align on best practices across Hikma Operating Units
  • Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures
  • Develops and drives Risk Management approach
  • Contributes in relevant Quality Governance meetings

Project Support
  • Leads and/or participates on departmental and/or cross-functional teams as Combination Product and Medical Device SME
  • Performs gap assessments of processes and procedures against relevant device regulations
  • Develops recommendations and proposals to address identified gaps and provides expert guidance for projects
  • Drives, as appropriate, key activities such as risk analysis, FMEA and threshold analysis for active projects
  • Drive required Statements of Work with consultants where needed to support specific product programs e.g. device reliability, human factor studies, threshold analysis, FMEA, and/or risk analysis
  • Drives change control support for Combination Product & Medical Device requirements assessment and deliverable review
  • Provide support for relevant investigations and CAPA(s)
  • Provides guidance on approach and regulatory responses support for health authority questions to support product approvals
  • Other duties as assigned
  • Predictable, consistent onsite attendance required

Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
  • B.S. in engineering field (e.g. pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device manufacturer or combination product manufacturer
  • M.S. in engineering field with 5+ years direct experience at a medical device manufacturer or combination product manufacturer

Business & Technical Expertise
  • Strong understanding of business development, lifecycle management, and long-term planning.
  • Subject matter expert in combination products and medical devices, including design controls, risk management, validation, reliability, and process controls.
  • Deep knowledge of pharmaceutical principles and complex dosage forms (e.g., nasal suspensions, dry powder inhalers, novel delivery systems).
  • Experienced in manufacturing, packaging, and device production processes.

Customer Focus
  • Champions quality and customer service excellence.
  • Aligns strategies to customer needs and market trends.
  • Establishes best practices to maintain industry-leading service standards.

Innovation & Change Leadership
  • Promotes a culture of innovation and continuous improvement.
  • Evaluates solutions against business goals and stakeholder impact.
  • Drives actionable strategies that enhance productivity and competitive advantage.

Communication & Influence
  • Effective communicator across diverse audiences; skilled in presentations, technical writing, and meeting facilitation.
  • Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Regulatory & Operational Excellence
  • Expert knowledge of pharmaceutical regulations (cGMP, FDA, DEA, ANDA requirements).
  • Strong project management experience leading cross-functional teams.
  • Able to work independently with minimal supervision.

Preferred Qualifications:
  • Experience with Class III/lifesaving combination products or medical devices; background in statistics and continuous improvement (Six Sigma Green/Black Belt preferred).
  • Strong critical thinking skills with a track record of completing complex projects and developing solutions to minimize risk and resolve issues.
  • Proven ability to manage multiple high-complexity projects, influencing cross-functional teams (PD, AD, DRA, Medical, QA, Operations, Warehouse) and external partners while meeting strict timelines.
  • Demonstrated decision-making capability, balancing risk vs. reward and independently driving tactical decisions (e.g., formulation, manufacturing processes, QbD strategy, experimental design).
  • Contributes to project planning, timelines, and budget adherence aligned with business goals.
  • Decisions primarily impact local operations with potential regional/global implications, including influence on regulatory timelines and product launch readiness.
  • Evaluates scientific and business risks to guide innovation and strategic direction.

What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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