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Biomedical Quality Assurance Jobs (NOW HIRING)

IT EXCEL LLC

QA Tester

Reston, VA Β· On-site

They are seeking a QA Tester to enhance IT capabilities and align them with business strategies ... Qualifications : Required : β€’ BS in Biomedical Engineering β€’ BS in Chemical Engineering β€’ ...

tulanectsi

The Quality Assurance Specialist I provides services to personnel through field consultations ... High School Diploma and four years of experience working in a biomedical research environment or ...

Sage Dental

Director, Quality Assurance

Boca Raton, FL Β· On-site

... biomedical waste, OSHA, and radiation regulations. β€’ Attend weekly meetings regarding new and ... dental quality assurance and patient safety. β€’ Build strong relationships with clinical and ...

IT EXCEL LLC

Qa Analyst

Orlando, FL Β· On-site

WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS ... Qualifications Qualifications : BS in Biomedical Engineering/ BS in Chemical Engineering/ Computer ...

IT EXCEL LLC

Qa Analyst

Orlando, FL Β· On-site

WE ARE LOOKING FOR FRESH GRADUATES FOR QA and Validation POSITIONS ... Qualifications Qualifications : BS in Biomedical Engineering/ BS in Chemical Engineering/ Computer ...

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Biomedical Quality Assurance information

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How much do biomedical quality assurance jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for biomedical quality assurance in the United States is $23.19, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $24.28 per hour, depending on experience, location, and employer.

What is biomedical quality assurance?

Biomedical Quality Assurance (QA) refers to the systematic processes and procedures used to ensure that biomedical products, such as medical devices and pharmaceuticals, meet established quality standards and regulatory requirements. QA professionals in this field develop, implement, and monitor protocols to maintain product safety, efficacy, and compliance throughout the manufacturing and development lifecycle. Their responsibilities often include auditing, risk assessment, documentation, and training to ensure continuous improvement and adherence to industry regulations. This role is essential for protecting patient safety and maintaining the integrity of biomedical products.

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

To thrive as a Biomedical Quality Assurance professional, you need a solid background in biomedical sciences or engineering, knowledge of regulatory standards (such as FDA, ISO 13485), and often a relevant degree. Familiarity with quality management systems (QMS), auditing tools, and certifications like Certified Quality Auditor (CQA) are commonly required. Attention to detail, analytical thinking, and effective communication are vital soft skills for ensuring compliance and facilitating cross-functional collaboration. These skills and qualifications are crucial for maintaining product safety, regulatory compliance, and the overall integrity of biomedical products.

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

Professionals in Biomedical Quality Assurance often face challenges related to keeping up with evolving regulatory requirements and ensuring compliance across complex, interdisciplinary teams. Managing documentation accuracy and maintaining clear communication between departments such as R&D, manufacturing, and regulatory affairs can also be demanding. To address these challenges, it’s important to stay current with industry standards, foster a culture of continuous improvement, and utilize robust quality management systems. Proactive collaboration and regular training can further help in mitigating compliance risks and streamlining workflows.

What is the difference between Biomedical Quality Assurance vs Biomedical Regulatory Affairs?

AspectBiomedical Quality AssuranceBiomedical Regulatory Affairs
CertificationsISO 13485, Six Sigma, GMPRegulatory Affairs Certification (RAC), ISO 13485
Work EnvironmentManufacturing, quality control labs, compliance departmentsRegulatory agencies, corporate compliance teams
Employer & Industry UsageMedical device companies, biotech firmsPharmaceutical and medical device companies, regulatory bodies
Common Search & ComparisonYesYes

Biomedical Quality Assurance focuses on maintaining product quality and compliance through inspections and standards, while Biomedical Regulatory Affairs manages regulatory submissions and ensures products meet legal requirements. Both roles are essential in the biomedical industry but serve different functions related to quality and compliance management.

Is biomedical quality assurance a stressful job?

Biomedical quality assurance professionals often work in regulated environments where attention to detail and compliance are critical, which can lead to stressful situations, especially when deadlines or audits are involved. However, the job typically involves structured processes, documentation, and collaboration, which can help manage stress levels. Overall, stress levels vary depending on workload, organizational support, and individual resilience.

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

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

Infographic showing various Biomedical Quality Assurance job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 80% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 83% Physical, 1% Hybrid, and 16% Remote job distribution, with an average salary of $48,237 per year, or $23.2 per hour.

Senior Quality Director

Waltham, MA β€’ On-site

Nova Biomedical Corporation
See more jobs at Nova Biomedical Corporationexternal

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 27 days ago

Job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.
Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.
Job Summary:
Nova Biomedical is seeking a Senior Quality Director, to lead corporate-level quality and compliance activities across Nova Biomedical's global manufacturing sites. This role is responsible for assuring company compliance with applicable regulatory and quality standards, including ISO/FDA QSR, IVDD, IVDR, ISO 13485, and ISO 14971. The Sr. Director, Quality will provide direct oversight of CAPA management, ISO/QSR employee training, quality metrics, validation, internal and external audit processes, and quality system improvements. This position will also manage day-to-day quality activities across global Nova Biomedical manufacturing sites and interact directly with management at Nova subsidiaries on quality assurance systems and process-related matters.
Responsibilities:
  • Provide leadership and support during external audits performed by regulatory bodies, including FDA and TUV, as well as audits conducted by partners, customers, and other auditing bodies.
  • Support and conduct internal audits of Nova Biomedical's Quality System.
  • Manage internal and external CAPAs, including appropriate action planning, risk assessment, and effectiveness verification.
  • Serve as Nova Biomedical's PLQC Chair.
  • Manage and execute NIRs and other failure investigations.
  • Manage Nova Biomedical's shipping hold processes and ensure timely interaction between functional groups.
  • Design and deliver employee quality training to support company-wide compliance.
  • Oversee the approval process for NCMRs as part of the MRB process.
  • Provide Supplier Quality Engineering support for the review and approval of SQE CAPAs.
  • Provide quality leadership for company improvement projects.
  • Oversee validation activities and ensure process effectiveness.
  • Ensure compliance with company procedures, processes, and applicable quality system requirements.
  • Develop and execute quality plans related to product development and new project initiatives.
  • Oversee quality metrics and KPIs for evaluation and reporting during Senior Management Reviews.
  • Ensure timely response and feedback to Nova Biomedical suppliers and ensure supplier-related issues are resolved without disrupting production processes.
  • Manage customer and partner qualifications and ongoing compliance maintenance activities, including SCARs, quality surveys, and quality agreements.
  • Provide quality support to Nova Biomedical subsidiaries.
  • Manage documents of external origin, including ISO standards, electrical standards, and related external regulatory or quality documents.
  • Interact cross-functionally with departments impacted by Nova Biomedical's Quality System, including R&D, Manufacturing, Engineering, Supplier Quality Engineering, Incoming Inspection, Purchasing, and Technical Support.

Experience Requirements:
  • Bachelor's degree in the sciences or another technical discipline, or 10+ years of quality assurance experience in the medical device or diagnostic industry.
  • 12+ years of medical diagnostic or medical device experience managing a quality program.
  • 12+ years of quality team management experience.
  • Working knowledge of GMP is required.
  • Demonstrated ability to apply root cause analysis tools and structured problem-solving methodologies to quality management system issues.
  • Skilled in performing and leading internal and external audits.
  • Proven track record driving process improvements.
  • Strong organizational, communication, and presentation skills.
  • Ability to communicate effectively with various functional departments to achieve successful outcomes.
  • Knowledge of LMS software.
  • Technical knowledge of Nova Biomedical-type products is a plus.
  • Certified Quality Auditor and/or Certified Quality Manager certification through ASQ is a plus, but not required.

Physical Requirements and Working Conditions:
  • Comfort with working at a computer for extended periods.
  • Capacity to lift and carry up to [25οΏ½50] pounds as required
  • Able to communicate effectively via phone, video, and written communication.
  • Occasional need to move about the office to access meetings or resources.

Why Work for Nova Biomedical
  • Flexible Medical, Dental, & Vision Coverage
  • Competitive 401k company match
  • Bonus Program, Generous PTO and paid holidays
  • Generous Tuition reimbursement
  • Hybrid and flexible work arrangements
  • Professional development, engagement and events
  • Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
  • Company subsidized cafeteria in our Waltham, MA office

Work Location: Hybrid work schedule, onsite in our Waltham, MA office
Targeted Salary Range: $220,000 - $300,000/year
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
About the Company
At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.
Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.
Explore what's next with us at novabiomedical.com
EEO Statement:
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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