Sr Quality Engineer - Post Market Data Analyst

New

JobgetherMedical Devices, Biotech

Based in United StatesFull-TimeSenior

Salary$66,000 - $115,500, depending on experience, location, and qualifications.

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Job Details

Experience: Bachelor’s degree with 5+ years of relevant experience, or a Master’s degree with 3+ years of relevant experience.
Required Skills: SQLMicrosoft Power BITableauMicrosoft ExcelData analytics

Bachelor’s degree in Engineering, Data Science, Statistics, Computer Science, Quality, or related field with 5+ years of experience, or Master’s with 3+ years.
Proficiency in business intelligence and reporting solutions using Power BI, Tableau, or similar.
Strong skills in statistical analysis and data management tools including SQL and Microsoft Excel.
Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA processes, and quality management systems.
Ability to analyze complex datasets and communicate insights to technical and non-technical stakeholders.
Experience in medical devices, in vitro diagnostics, biotechnology, or pharmaceutical industries (preferred).
Experience with Minitab, JMP, R, or Python (preferred).
ASQ Certified Quality Engineer (CQE) or experience supporting regulatory inspections (preferred).

Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses.
Ensure the accuracy, integrity, and governance of complaint and quality system data.
Provide analytical support for complaint investigations, root cause analysis, risk management, and CAPA effectiveness evaluations.
Collaborate with Quality Assurance, Regulatory Affairs, Product Development, Manufacturing, and Engineering teams.
Support internal and external audits, regulatory inspections, and compliance activities.
Improve business intelligence capabilities by identifying opportunities for automation and data-driven decision-making.

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