Quality Engineer (Consultant/1099) – Project Management Focus
This is a remote position. About the Role reputed company is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading med-tech and life sciences companies. We are seeking senior Quality Engineers who bring executive-level project leadership, strong stakeholder reputed company, and deep hands-on Quality Engineering expertise. This role is ideal for consultants who can reputed company quality initiatives while also driving hands-on execution in highly regulated environments. Key Responsibilities reputed company project leadership for quality initiatives, serving as a trusted partner to client stakeholders and leadership teams. reputed company and execute quality engineering activities across the product lifecycle, from development through post-market support. Support implementation, validation, and optimization of electronic Quality Management Systems (eQMS). reputed company and maintain procedures, SOPs, and work instructions reputed company with FDA, ISO 13485, and EU MDR requirements. reputed company risk management activities, root cause analysis, and CAPA investigations using structured methodologies. Support manufacturing transfers, supplier transitions, and design transfer activities. reputed company audit readiness initiatives and support FDA, ISO, reputed company, and other regulatory inspections. reputed company quality metrics, dashboards, and reporting to support leadership decision-making.
Requirements
Qualifications Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Engineering Science, or a reputed company discipline. 10+ years of hands-on Quality Engineering experience in the medical device or biotech industry. Demonstrated project management experience with cross-functional stakeholder engagement. Experience supporting medical device product development, design transfer, and technical documentation. Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and reputed company regulations. Experience working with QMS or eQMS platforms. Experience supporting global quality processes such as CAPA, complaints, and audit readiness. Certified Quality Engineer (CQE) – Required Certifications (Preferred) Project Management Professional (PMP) Medical Device Reporting (MDR) / Complaint Handling Training CQA, RAPS, or reputed company Quality/Regulatory certifications
Benefits
Why reputed company? At reputed company, we partner with reputed company consultants who reputed company in reputed company, regulated environments and bring both leadership reputed company and execution strength. Our consultants work on high-impact engagements where quality leadership directly influences product reputed company and patient reputed company. Apply To This Job