Sr Quality Engineer - Post Market Data Analyst in United States Embassy at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Quality Engineer - Post Market Data Analyst based in United States.

This role offers the opportunity to combine quality engineering expertise with advanced data analytics to improve product quality, regulatory compliance, and patient safety outcomes.
You will transform complex post-market quality data into actionable insights that support better business and operational decisions.
Working within a collaborative quality environment, you will partner with teams across regulatory, operations, manufacturing, and product functions.
The position plays a key role in strengthening quality systems through analytics, reporting automation, and continuous improvement initiatives.
You will contribute to data-driven strategies that enhance surveillance activities, risk management, and corrective action effectiveness.
This remote opportunity is ideal for a detail-oriented quality professional who enjoys solving complex problems through data and innovation.

The Senior Quality Engineer – Post Market Data Analyst will be responsible for leveraging quality data, analytics, and engineering knowledge to support post-market surveillance, improve quality processes, and provide meaningful insights to stakeholders. The role requires strong collaboration skills and the ability to translate data findings into practical improvements.

• Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses to monitor quality performance and identify emerging issues.
• Ensure the accuracy, integrity, and governance of complaint and quality system data through validation, reconciliation, audit trail management, and reporting improvements.
• Provide analytical support for complaint investigations, root cause analysis, risk management activities, and CAPA effectiveness evaluations.
• Collaborate with Quality Assurance, Regulatory Affairs, Product Development, Manufacturing, Engineering, and other cross-functional teams to identify trends and drive continuous improvement.
• Support internal and external audits, regulatory inspections, and compliance activities through accurate documentation, reporting, and quality system analysis.
• Improve business intelligence capabilities by identifying opportunities for enhanced reporting processes, automation, and data-driven decision-making.
• Contribute to maintaining effective quality management systems while supporting product reliability and customer safety objectives.

The ideal candidate brings a strong background in quality engineering, data analytics, and regulated environments, with the ability to combine technical expertise and business judgment to improve quality outcomes.

• Bachelor’s degree in Engineering, Data Science, Statistics, Computer Science, Quality, or another related technical discipline with 5+ years of relevant experience, or a Master’s degree with 3+ years of relevant experience.
• Experience developing and maintaining business intelligence and reporting solutions using platforms such as Power BI, Tableau, or similar visualization tools.
• Strong proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel.
• Experience with analytical tools such as Minitab, JMP, R, or Python is preferred.
• Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA processes, complaint handling, risk management, and quality management systems.
• Ability to analyze complex datasets, identify trends, and communicate insights clearly to technical and non-technical stakeholders.
• Strong problem-solving skills with attention to detail and a continuous improvement mindset.
• Experience in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or other regulated industries is preferred.
• Advanced certifications such as ASQ Certified Quality Engineer (CQE) and experience supporting regulatory inspections are considered advantages.
• Ability to collaborate effectively in a remote environment and communicate through virtual tools and presentations.

• Fully remote work arrangement within the United States.
• Competitive annual salary range of approximately $66,000 - $115,500, depending on experience, location, and qualifications.
• Eligibility for bonus or incentive compensation.
• Comprehensive health, dental, and vision insurance benefits.
• 401(k) retirement plan.
• Paid time off and employee wellness programs.
• Flexible work environment designed to support work-life balance.
• Opportunities for professional growth and development within a global science and technology organization.
• The opportunity to contribute to meaningful innovations that improve healthcare and scientific outcomes.