Sr. Product Quality Engineer

The Fountain Group; Alameda (CA); On-site; USD 92,000 - 99,000; Full time

Job summary

The Fountain Group in Alameda, CA is seeking a Sr. Product Quality Engineer to support investigations, data analysis, complaint trending, and risk identification in a regulated medical device environment.

The ideal candidate will have hands-on CAPA, root cause analysis, and quality data trending experience, with proficiency in Advanced Excel, JMP, Power BI, SQL, and/or Python. This is a 6-month contract with competitive hourly pay and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or a related technical field is required.
• Approximately 4+ years of relevant Quality Engineering experience in a regulated environment.
• Medical device experience is strongly preferred.
• Hands-on experience with CAPA, quality investigations, complaint handling/investigations, and root cause analysis.
• Experience performing quality data analysis, tracking, trending, and statistical evaluation.
• Strong understanding of risk management and Quality Systems.
• Experience in FDA/ISO-regulated environments and knowledge of 21 CFR Part 820 and ISO 13485.

Responsibilities

• Lead complaint, quality system, and post-market surveillance trending to identify risks.
• Analyze large datasets involving complaints, CAPAs, nonconformances, and manufacturing quality data.
• Identify recurring issues, failure patterns, and emerging quality concerns.
• Lead and support investigations, CAPA investigations, and root cause analysis.
• Use statistical and engineering methods to evaluate trends and risks, and determine escalation.
• Develop and implement CAPAs and verify their effectiveness.
• Create reports, dashboards, and visualizations to communicate findings.
• Present findings to leadership and quality review boards.
• Collaborate with Quality, Engineering, and Manufacturing to resolve issues.
• Support post-market surveillance, audits, and regulatory compliance.
• Drive continuous improvement through data-driven decisions.
• Provide guidance to junior engineers as needed.

Skills

Quality engineering

Data analytics

CAPA

Root cause analysis

Complaint investigations

Excel

JMP

Power BI

SQL

Python

Education

Bachelor's degree in Engineering

Tools

Power BI

SQL

Python

JMP

Excel

Job description

The Fountain Group is a national staffing firm and we are currently seeking a Quality Engineer - Manufacturing/Medical Device for a prominent client of ours. This position is in Alameda, CA 94502. Details for the position are as follows:

Sr. Product Quality Engineer

Location: Alameda, CA Duration: 6-Month Contract Pay Rate: $67–$72/hour W2

Position Summary

We are seeking a Senior Product Quality Engineer to support quality investigations, data analysis, complaint trending, and risk identification within a regulated medical device environment.

This role combines Quality Engineering with advanced data analytics and will focus heavily on investigating quality trends, identifying recurring or emerging product and process issues, and translating complex quality data into actionable insights.

The ideal candidate has hands-on experience with complaint investigations, CAPA, root cause analysis, and quality data trending, along with strong analytical capabilities using tools such as Advanced Excel, JMP, Power BI, SQL, and/or Python.

Key Responsibilities

• Lead complaint, quality system, and post-market surveillance trending activities to identify emerging product and process risks.
• Analyze large and complex datasets involving complaints, CAPAs, nonconformances, manufacturing quality, and other Quality System data.
• Identify recurring issues, failure patterns, adverse trends, and potential systemic quality concerns.
• Lead and support complaint investigations, CAPA investigations, root cause analysis, and nonconformance investigations.
• Use statistical and engineering methods to evaluate quality trends, assess risk, and determine appropriate escalation.
• Support the development, implementation, and effectiveness verification of CAPAs.
• Develop reports, dashboards, and data visualizations to communicate quality trends and investigation findings.
• Utilize analytical tools such as Advanced Excel, JMP, Power BI, SQL, and/or Python to track, trend, and evaluate quality data.
• Present technical findings, trends, risks, and recommendations to leadership and quality review boards.
• Partner cross-functionally with Quality, Engineering, Manufacturing, and other teams to investigate and resolve complex quality issues.
• Support post-market surveillance, risk management, audits, inspections, and regulatory compliance activities.
• Drive continuous improvement initiatives through data-driven decision-making.
• Provide technical guidance and mentorship to junior engineers as needed.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Approximately 4+ years of relevant Quality Engineering experience within medical device, pharmaceutical, biotechnology, or another highly regulated environment.
• Medical device experience strongly preferred.
• Hands-on experience with CAPA, quality investigations, complaint handling/investigations, and root cause analysis.
• Demonstrated experience performing quality data analysis, tracking, trending, and statistical evaluation.
• Strong understanding of risk management and Quality Systems.
• Experience working within an FDA and/or ISO-regulated environment.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Strong analytical, problem-solving, written, and verbal communication skills.
• Ability to independently investigate complex issues, manage multiple priorities, and communicate technical findings to cross-functional teams and leadership.
• Data Analytics & Technical Skills

Experience with one or more of the following:

• Advanced Microsoft Excel, including PivotTables, Power Query, advanced formulas, and analysis of large datasets
• JMP – highly preferred
• Power BI
• SQL
• Python
• Statistical analysis and Statistical Process Control (SPC)
• Data visualization and dashboard development
• Quality Management Systems (QMS) and complaint databases

Candidates are not expected to have every analytics tool listed. The strongest candidates will demonstrate how they have used analytical tools to evaluate quality data, identify trends or recurring issues, support investigations, and drive quality decisions.

Preferred Qualifications

• Medical device Product Quality or Post-Market Quality experience.
• Complaint trending and post-market surveillance experience.
• Experience identifying emerging product risks or recurring failure modes through quality data analysis.
• Experience with JMP and statistical quality analysis.
• Advanced Excel experience, particularly Power Query and PivotTables.
• Experience with Power BI, SQL, or Python for quality data analysis.
• Experience with process validation, MRB, and nonconformance management.
• Experience presenting quality trends, investigation findings, and recommendations to leadership or Quality Review Boards.

Ideal Candidate

The ideal candidate is a Quality Engineer who thinks like a Data Analyst — someone who can independently investigate complex quality issues while using data to identify trends, recurring failures, and emerging risks.

This individual will bring a strong combination of Quality Engineering, complaint/CAPA investigation experience, root cause analysis, statistical thinking, and hands-on data analytics, with the ability to turn quality data into clear findings and actionable recommendations.