Senior Quality Engineer (Remote - US)

Jobgether; United States; Remote; USD 115,000 - 160,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen erfahrenen Senior Quality Engineer, der in einem dynamischen und regulierten Umfeld der Medizintechnik tätig ist. Diese Schlüsselposition erfordert tiefes Wissen über Qualitätsstandards und regulatorische Anforderungen, insbesondere im Bereich Software als Medizinprodukt. Der ideale Kandidat wird eine proaktive Herangehensweise an kontinuierliche Verbesserungen und bereichsübergreifende Zusammenarbeit mitbringen. Wenn Sie leidenschaftlich an Qualitätssicherung interessiert sind und in einem unterstützenden Team arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

Wettbewerbsfähiges Gehalt

Jährlicher Bonus und Aktienoptionen

Flexible Remote-Arbeitsumgebung

Gesundheits-, Zahn- und Sichtversicherung

Bezahlte Freizeit und Unternehmensfeiertage

Fortlaufende Schulungs- und Entwicklungsmöglichkeiten

Inklusive und unterstützende Teamkultur

Qualifications

• 6-8 Jahre Erfahrung in der Medizintechnik mit Schwerpunkt auf Qualitätsengineering.
• Starke Kenntnisse der ISO-Standards und regulatorischen Anforderungen.

Responsibilities

• Leitung der Qualitätsunterstützung für Softwareveröffentlichungen.
• Zusammenarbeit mit regulatorischen Behörden zur Einhaltung der Qualitätsstandards.

Skills

Qualitätsengineering

Risikomanagement

ISO 13485

ISO 14971

21 CFR 820

Audits leiten

Kommunikationsfähigkeiten

Projektmanagement

Education

Bachelor-Abschluss in einem wissenschaftlichen oder ingenieurtechnischen Fach

Certified Quality Auditor (CQA)

Job description

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior Quality Engineer in the United States.

We are seeking a seasoned Senior Quality Engineer to support quality assurance efforts in a fast-paced, highly regulated medical device environment. This role will play a key part in ensuring the quality and compliance of software-based products, including those utilizing AI/ML technologies. The ideal candidate will bring deep knowledge of quality standards, risk management, and regulatory compliance, with a proactive approach to continuous improvement and cross-functional collaboration. The position requires experience with software as a medical device (SaMD) and a strong understanding of ISO and FDA regulations.

Accountabilities:

• Lead quality support for frequent software releases, including risk assessments and cross-functional process improvements
• Manage internal and external audits, ensuring timely resolution of non-conformities and system updates
• Collaborate with regulatory agencies and external partners to maintain compliance across Quality Systems
• Contribute to risk management processes, including FMEAs and ongoing product lifecycle reviews
• Drive the CAPA and non-conformance processes, identifying root causes and implementing corrective actions
• Conduct quality impact assessments for changes to regulations and standards, ensuring timely communication and adaptation
• Support and train internal teams on quality system procedures and continuous improvement initiatives
  
  
  

Requirements

• 6-8 years of experience in the medical device industry with a focus on quality engineering
• Strong knowledge of ISO 13485, ISO 14971, and 21 CFR 820
• Experience with Software as a Medical Device (SaMD), including AI/ML-based technologies
• Proven ability to lead audits and interface with regulatory bodies and external partners
• Skilled in risk management activities and quality documentation
• Excellent communication, project management, and cross-functional collaboration skills
• Bachelor's degree in a scientific or engineering discipline required; Certified Quality Auditor (CQA) is a plus
  
  
  

Benefits

• Competitive base salary ($115,000-$160,000)
• Annual cash bonus and stock options
• Flexible remote work environment ()
• Health, dental, and vision insurance
• Paid time off and company holidays
• Ongoing training and professional development opportunities
• Inclusive and supportive team culture
  
  
  

Jobgether hiring process disclaimer

This job is posted on behalf of one of our partner companies. If you choose to apply, your application will go through our AI-powered 3-step screening process, where we automatically select the 5 best candidates.

Our AI thoroughly analyzes every line of your CV and LinkedIn profile to assess your fit for the role, evaluating each experience in detail. When needed, our team may also conduct a manual review to ensure only the most relevant candidates are considered.

Our process is fair, unbiased, and based solely on qualifications and relevance to the job. Only the best-matching candidates will be selected for the next round.

If you are among the top 5 candidates, you will be notified within 7 days.

If you do not receive feedback after 7 days, it means you were not selected. However, if you wish, we may consider your profile for other similar opportunities that better match your experience.

Thank you for your interest!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Non-profit Organizations and Primary and Secondary Education

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