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Costa Rica Medical Device Quality Jobs in Oregon

A-dec, Inc.

Manager, Quality Assurance

Newberg, OR · On-site

Knowledge of international standards and regulations (e.g., ISO 13485, MDSAP, FDA 21 CFR 820, CMDR SOR/98-282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745) and quality ...

Aerotek

General Production Worker

Newberg, OR

$18/hr

Follow standard protocols related to medical device manufacturing, including adherence to documented procedures and quality requirements. Essential Skills * Ability to operate production and assembly ...

Core4ce Careers

... high-quality visual diagrams and highly accessible documentation. Responsibilities * System ... Work closely with network engineers, clinical engineers, medical device security teams, software ...

Acumed LLC

Quality Engineer 2

Hillsboro, OR · On-site

$85 - $120/hr

Job Scope The NPI Quality Engineer II leads quality planning and ensures the quality of new ... Implantable medical device experience preferred. * Knowledge of FDA21CFR820, ISO13485, ISO14971 ...

New

Marmon

Quality Engineer 2

Hillsboro, OR · On-site

$78K - $101K/yr

Job Scope The NPI Quality Engineer II leads quality planning and ensures the quality of new ... Implantable medical device experience preferred. * Knowledge of FDA 21 CFR 820, ISO 13485, ISO ...

Bausch + Lomb

Product Cybersecurity Architect

OR · On-site +1

Experience in medical device, healthcare, or other regulated industries, and/or working within a quality-managed or GxP regulated environment. * Working knowledge of medical device cybersecurity ...

PTS Diagnostics

Be Seen First

Medical Device Sales Associate (WA/OR/ID/MT/WY)

Portland, OR · On-site

$60K - $75K/yr

Some technical background is preferred QUALITY COMMITMENT This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a "quality in everything ...

Marmon Holdings, Inc.

Senior Quality Engineer

Hillsboro, OR · On-site

$96K - $130K/yr

Direct experience working with implantable devices preferred. * 3 - 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive ...

Marmon

Senior Quality Engineer

Hillsboro, OR · On-site

$96K - $130K/yr

Direct experience working with implantable devices preferred. * 3 - 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive ...

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

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 Oregon?

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

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

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

Costa Rica Medical Device Quality jobs near you

Manager, Quality Assurance

A-dec, Inc.

Newberg, OR • On-site

Full-time

Re-posted 11 days ago

A-dec rating

8.8

Company rating: 8.8 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

2nd of 51 rated furniture manufacturers

Job description

At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding.
Overview
The Quality Assurance (QA) Manager is responsible for protecting A-dec's reputation for reliable, quality dental equipment by ensuring A-dec's Quality Management System meets or exceeds regulatory, company, and customer requirements. They are responsible for leading a team of QA Specialists and Engineers to deliver effective quality systems, processes, and insights that drive product and process improvement while balancing quality with productivity.
JOB DUTIES AND RESPONSIBILITIES:
  • Provides team leadership that facilitates efficient and effective support of enterprise quality management for product and process quality.
  • Provides technical guidance and coaching to team through communicating job expectations, planning, monitoring, and appraising job results to ensure department goals are met and promoting employee personal growth and development.
  • Action-oriented leader with strong execution skills, deeply embedded in the daily function and technical execution of quality duties.
  • Responsible for managing, supporting, overseeing, and improving A-dec's Quality Management System (QMS). Actively participates in internal and external (ISO, FDA, etc.) audits that assess the effectiveness of the QMS.
  • Leads departmental and enterprise-level quality initiatives, translating strategic direction into scalable, actionable systems, tools, and processes.
  • Leads process creation and improvements; drives process adoption; operationalizes systems and processes throughout organization; partners with a broad network of A-dec Engineers and Managers.
  • Develops and maintains the appropriate metrics to track corporate quality; performs quality data analytics; partners with cross-functional subject matter experts to extract insights, uncover trends, inform decisions, and drive improvements.
  • Serves as an organization-wide technical expert in advanced quality disciplines by applying an extensive and diversified knowledge of advanced quality techniques, procedures, and criteria.
  • Drives quality capability development across A-dec through training and using established processes such as root cause analysis and corrective and preventive action.
  • Fosters the creation and application of improved quality methods, systems, and solutions to elevate product quality and strengthen A-dec's market competitiveness.
  • Continuously evaluates and improves quality procedures, workflows, and work instructions to streamline operations, enhance team effectiveness, and strengthen alignment with A-dec's Quality Management System.

QUALIFICATIONS:
Knowledge, Skills, and Abilities
  • Knowledge of international standards and regulations (e.g., ISO 13485, MDSAP, FDA 21 CFR 820, CMDR SOR/98-282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745) and quality concepts (e.g. statistical analysis, root cause analysis, and quality metrics/analytics).
  • Must have excellent interpersonal skills; written and verbal communication for dealing with internal and external customers (e.g. A-dec department leaders, regulatory agencies), along with strong attention to detail and a high level of customer focus.
  • Ability to organize, coach, and lead cross-functional teams in addition to having strong organizational and time management skills; exercise good judgement using risk-based decision making, and use resources effectively.
  • Requires strong analytical skills, quality system expertise, and the ability to manage multiple priorities in a fast-paced manufacturing environment.
  • Proficient with all Microsoft Office Suite applications and experience in project and database management.

Education and Experience
  • Requires a bachelor's degree in business or engineering or equivalent and a minimum of ten years of experience in Quality or related field with 3-5 years in a leadership experience. Leadership may include people leadership, technical leadership, and/or project leadership with demonstrated ability to coach and mentor others, support team member development, and influence outcomes through effective leadership and collaboration.
  • Generally requires American Society of Quality (ASQ) certification.

Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not to be construed as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. A-dec reserves the right to assign job duties and days and hours of work based on factors such as workload requirements, staffing levels, and customer demands.
At A-dec, we value our people and show it by prioritizing an inclusive culture, total well-being, and opportunities for learning and career advancement.
A background check and screen for the illegal use of drugs is required.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor"
A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas.

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