Quality Engineer
Quality Engineer Needed for a Commercial Stage Medical Technology Company
- Engineering | Wearables | Diabetes
- Germantown, MD
- $80,000 - 95,000 + complete benefits package
We are seeking a detail-oriented Quality Engineer to join our team, where you'll play a key role in resolving technical challenges, delivering prompt feedback to customers, and assisting in the evaluation of new software and hardware applications. This role also involves documenting and supporting technical assessments and investigative efforts related to customer complaints, ensuring timely resolution in alignment with internal protocols.
Key Responsibilities:
- Serve as a liaison with the Customer Service team to address and resolve escalated technical issues.
- Diagnose and resolve hardware/software problems efficiently while managing multiple cases simultaneously.
- Collaborate with Engineering, Quality Assurance, and other relevant teams to gather insights for root cause analysis and ensure accurate documentation of complaint resolutions.
- Conduct failure analysis on returned products and potential medical device issues using lab testing, data interpretation, and standard procedures.
- Participate in or support internal and external audits concerning complaint handling and documentation.
- Maintain awareness of regulatory requirements and ensure all technical complaint data is collected and recorded in compliance with applicable standards.
Required Skills and Qualifications:
- Familiarity with regulatory frameworks including 21 CFR 820, 21 CFR 803, ISO 13485, ISO 14971, and MEDDEV Vigilance Guidance.
- Understanding of the European Medical Device Regulation (EU MDR 2017/745).
- Strong technical writing skills with the ability to translate complex investigations into clear, concise reports for non-technical audiences.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Prior experience in GMP or ISO-regulated environments is advantageous.
- Comfortable using customer support platforms and technical databases.
- Quick learner with the ability to adapt to various software tools.
- 1-2 years of experience in medical device complaint documentation and processing preferred.
- Proven ability to work effectively across departments.
- Bachelor's degree in Engineering or a related scientific discipline is preferred.
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