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Quality Assurance Biomedical Engineering Jobs (NOW HIRING)

GRIFOLS, S.A.

Sr Quality Assurance Specialist

San Diego, CA · On-site

$87K - $120K/yr

The Sr Quality Assurance Specialist manages independently nonconformances, andCAPA records ... Requires BA or BS in biology, chemistry, biochemistry or biomedical engineering. * Quality ...

Grifols

Sr Quality Assurance Specialist

San Diego, CA · On-site

$87K - $120K/yr

The Sr Quality Assurance Specialist manages independently nonconformances, andCAPA records ... Requires BA or BS in biology, chemistry, biochemistry or biomedical engineering. * Quality ...

Blue Water Thinking

Biomedical Engineer / LMDI SME

... quality assurance, and life-cycle management. * Advise clinical and administrative staff on medical ... Experience within a medical center and Biomedical Engineering department * OR, Experience working ...

Grifols, S.A

Sr Quality Assurance Specialist

San Diego, CA · On-site

$87K - $120K/yr

... or biomedical engineering (Quality certification (from American Society for Quality or equivalent ... Represents QA interests on special projects related to area of expertise. * Coordinates regional ...

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Quality Assurance Biomedical Engineering information

What is quality assurance in biomedical engineering?

Quality Assurance (QA) in Biomedical Engineering involves ensuring that medical devices and equipment meet specific safety, performance, and regulatory standards before they reach the market or are used in healthcare settings. QA professionals develop and implement testing protocols, perform inspections, document compliance, and coordinate with regulatory agencies like the FDA. Their work is critical for maintaining patient safety, reducing risks, and ensuring products consistently meet stringent industry requirements.

What are the key skills and qualifications needed to thrive as a quality assurance biomedical engineer?

To thrive as a Quality Assurance Biomedical Engineer, you need a solid background in biomedical engineering principles, quality control processes, and relevant regulatory standards, often supported by a degree in biomedical engineering or a related field. Familiarity with quality management systems (QMS), ISO 13485 standards, and tools like statistical process control software is typically required. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for excelling in this role. These competencies are essential for ensuring the safety, compliance, and reliability of medical devices and products in the healthcare industry.

What are some typical challenges faced by quality assurance professionals in biomedical engineering, and how can they be addressed?

Quality Assurance professionals in Biomedical Engineering often encounter challenges such as navigating complex regulatory requirements, ensuring product safety and efficacy, and maintaining thorough documentation. Keeping up with evolving standards (like ISO 13485 and FDA regulations) can be demanding, requiring ongoing learning and meticulous attention to detail. Collaborating closely with cross-functional teams—including R&D, manufacturing, and regulatory affairs—helps address these issues, as does implementing robust quality management systems to streamline compliance and continuous improvement.

What are popular job titles related to Quality Assurance Biomedical Engineering jobs?

For Quality Assurance Biomedical Engineering jobs, the most frequently searched job titles are:

Biomedical Engineering Support Specialist III

Iowa City, IA • On-site

Aretum
See more jobs at Aretumexternal

$45K - $70K/yr

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 7 days ago

Job description

Public Trust Eligibility Required
About Veterans Engineering (A wholly owned subsidiary of Aretum)
Veterans Engineering, a wholly owned subsidiary of Aretum, is dedicated to delivering high-impact professional services and mission-focused solutions in support of government customers. Backed by Aretum's broader capabilities and resources, Veterans Engineering brings specialized expertise, operational discipline, and a strong commitment to service excellence. The organization is focused on supporting critical programs through a skilled workforce, responsive delivery, and a deep understanding of client mission needs.
Job Summary
Veterans Engineering is searching for a talented Biomedical Engineering Support Specialist III to join our dynamic team. In this critical role, you will provide advanced biomedical engineering support to healthcare facilities, ensuring all medical equipment is safe, functional, and compliant with healthcare regulations. You will be responsible for troubleshooting complex medical devices, conducting preventive maintenance, and providing training to staff on proper equipment use and safety practices. Our ideal candidate is detail-oriented, possesses strong analytical skills, and has a deep understanding of medical technology and regulations in the healthcare industry. This position is perfect for someone who is passionate about improving patient outcomes through high-quality engineering support and has a commitment to excellence in service delivery. We value diversity and strongly encourage candidates from all backgrounds, including those with military experience, to apply.
Responsibilities
  • Perform incoming inspection and periodic inspection on both new and current medical equipment or devices
  • Perform quality assurance check to assure that equipment conforms to manufacturer literature for components, parts, and performance
  • Install, calibrate and test medical equipment or devices in accordance with manufacturer's literature, certification to perform installation actions, and/or biomedical engineering department authorization to perform installation
  • Perform Inventory and Asset Management of medical equipment and document according to VA process and procedures
  • Perform preventive maintenance checks
  • Perform troubleshooting of equipment or device malfunction to determine source or cause of defect or malfunction
  • Perform scheduled and/or unscheduled maintenance
  • Document using VA's electronic system according to the VA standards

Requirements
  • A minimum of five years of hospital or healthcare experience performing medical equipment maintenance
  • Associate degree or higher in an applied science or equivalent military training
  • Demonstrated competency to perform operational verification procedures, planned maintenance, and repair service on various types of medical equipment
  • Understanding of regulatory agencies' requirements, industry regulatory requirements and International Standard Organization standards
  • Familiarity with the setup and application of test equipment
  • Ability to read, analyze, and interpret technical literature, schematics, and drawings

Travel Requirements
Travel to client locations is required for this position and may vary based on project needs.
EEO Statement
Veterans Engineering is committed to fostering a workplace rooted in excellence, integrity, and equal opportunity for all. We adhere to merit-based hiring practices, ensuring that all employment decisions are made based on qualifications, skills, and ability to perform the job, without preference or consideration of factors unrelated to job performance.
As an Equal Opportunity Employer, Veterans Engineering complies with all applicable federal, state, and local employment laws.
We are proud to support our nation's veterans and military families, providing career opportunities that honor their service and experience.
Equal Opportunity Employer/Veterans/Disabled
U.S. Work Authorization
Due to federal contract requirements, only U.S. citizens are eligible for this position. This position supports a federal government contract and requires the ability to obtain and maintain a Public Trust or Suitability Determination, depending on the agency's background investigation requirements.
Benefits
  • Salary Range: $45,000-$70,000 annually. Final compensation will be determined based on factors including education, experience, qualifications, skills, and applicable contract requirements.
  • Health Care Plan (Medical, Dental & Vision)
  • Life Insurance (Basic, Voluntary & AD&D)
  • Paid Time Off
  • Family Leave (Maternity, Paternity)
  • Short Term & Long-Term Disability
  • Training & Development

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