Business
Quality and Regulatory Senior Engineer
Hi! We are HTD, a digital health company based in Lodz and New York City. We are on a mission to create a more human-centric, accessible, and efficient healthcare system.
Apply nowMain requirements
What we need from you:
- Education: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
- Experience: Minimum of 5 years in Quality Assurance and Regulatory Affairs within the medical device or health tech industries, proven experience in software quality management within an Agile development environment.
- Regulatory Knowledge: In-depth knowledge of FDA 21 CFR 820, ISO 13485:2016, ISO 14971:2019, and IEC 62304 and experience with regulatory submissions and managing medical device technical files.
- Audit Experience: Demonstrated ability to Lead internal and external audits, Certified Internal Auditor (preferred).
- Documentation Skills: Proficient in creating and managing quality documentation and risk management according to industry standards..
- Independence: Ability to work independently and effectively without supervision.
- Language Skills: Fluent in English, both written and spoken.
Preferred Qualifications
- Software Tools: Basic knowledge of Jira and experience with software systems supporting regulatory compliance (e.g., Ketryx, Matrix Requirements).
- Industry Experience: Experience specifically in SaMD development and understanding of global SaMD regulations.
- Soft Skills: Strong analytical, problem-solving, and communication skills. Ability to collaborate effectively with cross-functional teams.
- Certifications: Additional certifications in Quality Management (e.g., CQE, CQA) or Regulatory Affairs (e.g., RAC) are advantageous.
Quality Assurance Leadership
- Lead Quality Initiatives: Oversee the development, implementation, and continuous improvement of quality assurance processes and procedures related to SaMD.
- Quality Management System (QMS): Maintain and enhance HTD’s QMS for SaMD, ensuring compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, IEC 62304, and other relevant standards.
- Continuous Improvement: Continuously assess and improve QMS procedures and processes to enhance efficiency, effectiveness, and compliance.
- Documentation Management: Develop, manage, and review technical documentation, Design History Files, Design Controls, risk assessments, and qualification/validation documents.
- Internal Audits: Conduct internal quality audits to ensure adherence to QMS and identify areas for improvement.
- Training & Awareness: Provide QMS-related training and promote quality awareness across the organization.
Serve as the Quality representative in front of the client to ensure optimal communication and alignment.
Regulatory Compliance
- Regulatory Expertise: Serve as the subject matter expert on regulatory requirements, advising on the impact of regulations on product changes and development.
- Regulatory Documentation: Prepare and review technical documentation for regulatory submission, ensuring all documentation meets FDA and international standards.
- Audit Representation: Act as the company representative during internal and external audits, including ISO audits.
- Design Verification & Transfer: Oversee activities related to Design Verification and Design Transfer to ensure regulatory compliance throughout the product lifecycle.
Sustaining Engineering Support
- Continuous Improvement: Identify and implement process improvements to enhance product quality and regulatory compliance.
- Collaboration: Work closely with cross-functional teams, including Product Owners (POs), software development, and design teams, to ensure quality standards are integrated into all stages of SaMD development.
Project Leadership
- Cross-Functional Leadership: Serve as the Quality Lead on multiple Medical Device Software projects, providing guidance and ensuring alignment with quality and regulatory standards.
- Technical Expertise: Provide technical quality expertise for various medical device projects and combination products during design and development phases.
- Timeline Management: Keep Leadership informed of project development timelines, progress, and challenges related to quality and regulatory aspects.
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100% remote friendly
Work from any location within Poland. We have no fixed expectations related to you being in the office.
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Educational budget
Opportunity for development with education budget. Are you interested in a certified training or international conference? No problem, the choice is yours.
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HARDWARE SECOND TO NONE
We provide you with the tools you need to work - MacBook, additional monitor, and Apple accessories, such as Air Pods or an additional keyboard.
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Growth system
Our promotion system is based on competence trees and evaluation of your performance. We want you to grow within our company.
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Health & life
HTD covers private medical care and life insurance. Just in case.
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Membership cards
Multisport Plus & Multilife member card or cinema tickets.
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Work-life balance
Your well-being is important to us. That’s why we offer Paid days off on each contract, HTD Workation, company-wide parties once a year, and opportunities for team integrations every quarter.
RECRUITMENT PROCESS
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1
CV verification
We will review your application.
Be sure to address all of our requirements. -
2
SCREENING CALL
We will invite you to a 30-minute screening call. We’ll be most interested in getting to know you better.
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3
ENGLISH AUDIT
We will send you an invitation to perform an English language audit. We will send the finished report to you.
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4
TECHNICAL INTERVIEW
We will invite you to an online technical interview that will last between one to two hours. We will mainly ask you about your studies and technical skills.
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5
FINAL DECISION WITH FEEDBACK
Candidates from the Technical Interview step will receive feedback about their performance. The selected candidate who met our requirements and successfully completed the recruitment process will receive an offer.