SENIOR QUALITY ASSURANCE ENGINEER
MedAcuity
Summary
The Senior Quality Assurance Engineer will work closely with internal and external project teams, cross-functionally throughout the project life cycle primarily in the MedTech space. The candidate will be adept at remediating legacy quality systems, and ensuring consistent, compliant project execution. They will be responsible for auditing processes, developing and improving QMS procedures, and ensuring alignment with regulatory and industry standards.
Job description
JOB SUMMARY
The Senior Quality Assurance Engineer will work closely with internal and external project teams, cross-functionally throughout the project life cycle primarily in the MedTech space. The candidate will be adept at remediating legacy quality systems, and ensuring consistent, compliant project execution. They will be responsible for auditing processes, developing and improving QMS procedures, and ensuring alignment with regulatory and industry standards.
RESPONSIBILITIES
- Contribute to or lead assessment engagements for medical device products in terms of completeness, conformance, and compliance as it relates to a Quality Management System (QMS) and associated QMS elements and Design and Development File and associated design artifacts.
- Author, remediate, and improve QMS elements including SOPs and Wis as well as project specific documents such as Quality Management Plans, Verification and Validation Plans, Risk Management Plans, and CAPAs.
- Partner with project teams and clients to ensure conformance to requirements of 21 CFR Part 820, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy, and Security.
- Provide teams with technical support for QA / Regulatory compliance activities.
- Participate in CAPA processes, risk analysis, complaint management, and internal auditing.
- Identify, develop, and execute process improvements, lead continuous improvement initiatives and drive changes cross-functionally.
- Develop and deliver effective training materials tailored to engineering, quality, and leadership audiences.
- Support internal as well as external audits and other Quality Assurance functions.
QUALIFICATIONS
- 8+ years of professional background in a similar QA / Regulatory function within a medical device environment with a focus on software process compliance.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and Risk Management standard ISO 14971.
- Experience with QMS improvements, documentation authoring, and DHF gap analysis.
- Production expertise in software development and Quality Assurance in medical device, pharmaceutical, or related regulated fields.
- Exposure to working in a professional services environment, communicating with primary stakeholders from internal consultancy and client management.
- Proficiency with Root Cause analysis and Corrective Actions (CAPAs).
PREFERRED SKILLS
- Certified Quality Engineer preferred and / or Auditor Certification desired.
- Proficiency in cyber-security regulations and its integration with risk management activities.
- Direct experience with requirements development, analysis, verification, and validation.
- Prior work history with software tools such as eQMS and document control systems such as Master Control, Arena, Veeva, etc.
EDUCATION
- Bachelor's degree in Computer Science, Electrical Engineering, or other STEM related fields OR equivalent experience in a comparable role.
Requirements
- 8+ years of professional background in a similar QA / Regulatory function within a medical device environment with a focus on software process compliance.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and Risk Management standard ISO 14971.
- Experience with QMS improvements, documentation authoring, and DHF gap analysis.
- Production expertise in software development and Quality Assurance in medical device, pharmaceutical, or related regulated fields.
- Exposure to working in a professional services environment, communicating with primary stakeholders from internal consultancy and client management.
- Proficiency with Root Cause analysis and Corrective Actions (CAPAs).
- Certified Quality Engineer preferred and / or Auditor Certification desired.
- Proficiency in cyber-security regulations and its integration with risk management activities.
- Direct experience with requirements development, analysis, verification, and validation.
- Prior work history with software tools such as eQMS and document control systems such as Master Control, Arena, Veeva, etc.
- Bachelor's degree in Computer Science, Electrical Engineering, or other STEM related fields OR equivalent experience in a comparable role.
Benefits
- Medical, Dental & Vision
- Health Reimbursement Arrangement
- Flexible Spending Accounts
- 401(k) with company match
- Company paid life insurance
- Company paid disability insurance
- Voluntary life insurance
- Employee assistance programs
- Recognition awards
- Vacation time
- Sick time
- Company holidays
Company overview
MedAcuity is a specialized medical device software development company that focuses on creating innovative software solutions for the healthcare and medical technology sectors. The company provides comprehensive software engineering services specifically tailored for medical device manufacturers, helping them navigate the complex regulatory landscape while delivering cutting-edge digital health solutions. MedAcuity's expertise spans across various aspects of medical device software development, including embedded systems, mobile applications, cloud-based platforms, and AI-driven diagnostic tools. Their team of experienced engineers and regulatory specialists work closely with clients to develop FDA-compliant software that meets stringent quality standards and safety requirements. The company plays a crucial role in bridging the gap between medical device hardware and advanced software capabilities, enabling healthcare providers to deliver more precise, efficient, and personalized patient care through technology-enabled medical solutions.