Sr. Product Quality Engineer

Job Title: Sr. Product Quality Engineer



Location: Alameda, CA



Duration: 06 Months

Position Overview:
We are seeking a Senior Product Quality Engineer with strong experience in medical device complaint tracking, trending, post-market surveillance, root cause analysis, and data analytics. The ideal candidate will be experienced in identifying complaint trends, investigating potential risks and drivers, and presenting data-driven findings to stakeholders.

Required Qualifications:

• 4 5+ years of experience in the medical device industry, preferably with complaint handling and complaint trending
• Strong experience with CAPA and Root Cause Analysis
• Proven data analytics experience
• Advanced Microsoft Excel skills
• Strong communication and presentation skills
• Excellent technical writing and documentation skills
• Strong critical thinking and problem-solving abilities
• Experience with SQL, Python, and Power BI is highly preferred

Preferred Qualifications:

• Python scripting experience
• SQL query development
• Power BI dashboard and data visualization experience
• Medical device complaint trending and post-market surveillance experience
• Exposure to statistical techniques or SPC
• Pharmaceutical industry experience may be considered in lieu of medical device experience

Key Responsibilities:

• Track and trend product complaints over time
• Identify trends, risks, patterns, and key drivers within complaint data
• Conduct investigations into identified complaint trends
• Perform root cause analysis and support appropriate corrective actions
• Develop detailed and well-documented investigation reports
• Analyze large datasets using SQL, Python, Power BI, and advanced Excel
• Present analytical findings and investigation results to cross-functional stakeholders
• Apply critical thinking and data-driven approaches to identify potential product quality risks
• Support post-market surveillance and quality improvement initiatives

Experience Level:

• Minimum 4 5 years of relevant industry experience
• Strong preference for candidates with direct medical device complaint/trending experience
• Candidates with 8 10 years of experience may also be considered based on relevant expertise and role alignment
• Pharmaceutical industry candidates may be considered if they possess strong complaint investigation, CAPA, root cause analysis, and data analytics experience

Top Skills:

• Root Cause Analysis
• Data Analytics SQL, Python, Power BI, Advanced Excel
• Communication & Presentation
• Technical Writing & Documentation
• Critical Thinking
• Medical Device Complaint & Trending Experience
• CAPA