Sr. Product Quality Engineer

The Fountain Group is seeking a Senior Product Quality Engineer for a 6-month contract position in Alameda, CA (94502). Pay rate: $67-$72/hour W2.

About the Role

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 on investigating quality trends, identifying recurring or emerging product and process issues, and translating complex quality data into actionable insights.

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.

Requirements

• 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.

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.

Pay

$67-$72/hour W2.

Schedule

6-month contract.