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Job Description
Quality/System Engineer #26-05055
$70-$75 per year
Buffalo, NY
Remote Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Quality/System Engineer.
Position Type:
Contract
On-Site Required:
Experience:
5-8 years of experience in quality or system engineering within the medical device industry, ideally with demonstrated experience with electromechanical medical devices that incorporate software, and familiarity with software development lifecycle processes and system-level product development.
Design Controls:
Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
Traceability:
Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
Regulatory Knowledge:
In-depth knowledge of US Medical Device Regulations (21 CFR), EU Medical Device Regulations (EU2017/745), ISO 13485, IEC 62304, and other applicable standards for medical devices.
Collaboration:
Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
Strong verbal and written communication in English.
Strong analytical and problem-solving skills.
Ability to manage and prioritize multiple tasks in a fast-paced environment.
Detail-oriented with a commitment to accuracy.
Proactive and able to work independently or as part of a team.
Strong organizational and technical writing skills.
Preferred Qualifications:
Gap Assessments:
Experience conducting quality system, technical documentation, or DHF gap assessments.
Risk Management:
Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971).
Design V&V Experience:
Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements.
Software Assessments:
Experience with
IEC 60601
series standards, IEC 62366-1, and cybersecurity requirements for medical devices.
Development Specifics:
Experience with software development, electrical safety, sterilization, and usability engineering.
Software and Tools:
Experience with requirements management tools, traceability software, and common V&V tools.
Responsibilities:
Gap Assessments:
Conduct comprehensive gap assessments of technical documentation against
ISO 13485
2016, 21 CFR Part 820, EU MDR 2017/745, and applicable medical device standards. Additionally, evaluate the completeness, consistency, and adequacy of the design and development documentation for electromechanical medical devices containing software. Lastly, identify compliance gaps, deficiencies and areas that require remediation to support regulatory readiness.
Design Controls:
Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with
ISO 13485
2016, 21 CFR Part 820, EU MDR 2017/745, and other applicable international standards and guidance.
Traceability:
Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
User Needs to
Design Validation:
Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive technical documentation and validation documentation.
Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
Software Assessments:
Review software lifecycle documentation and supporting evidence for compliance with applicable standards, including
IEC 62304.
Evaluate system-level integration documentation for electromechanical devices that combine hardware, software, and user interfaces.
Cross-Functional Collaboration:
Work closely with quality, regulatory, software, electrical, mechanical, and systems engineering teams to obtain and review documentation and clarify assessment findings.
Documentation and Reporting:
Prepare and maintain detailed documentation to report observations, compliance gaps, risks, and recommended corrective actions, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
Continuous Improvement:
Identify areas for process improvements in design control, traceability methods, and technical documentation and implement changes that enhance the efficiency and effectiveness of product development. Get in
Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more. #LI-VK1
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