Principal Quality Engineer

Leads advanced post-market surveillance, statistical analysis, complaint trending, risk analysis, and data visualization activities supporting medical device quality and safety monitoring.

Job Requirements

• Bachelor’s degree in a STEM discipline.

• 8+ years of experience with post-market surveillance, data analytics, and/or statistical analysis.

• Experience within the medical device industry.

• Experience with complaint handling or quality engineering.

• Knowledge of post-market surveillance and risk management principles.

• Understanding of Statistical Process Control (SPC) principles and methodologies.

• Experience performing advanced statistical analyses and interpreting complex datasets.

• Proficiency with Python and/or R.

• Experience with SQL and relational databases.

• Experience developing Power BI dashboards and data visualization tools.

Preferred Skills

• Experience supporting complaint trending, signal detection, or safety monitoring activities.

• Knowledge of machine learning methods and practical applications.

• Experience with process automation and analytical tool development.

• Experience within medical device, pharmaceutical, biotechnology, or other regulated industries.

Job Responsibilities

• Lead analysis of post-market surveillance, complaint, quality, and product performance data.

• Perform advanced statistical analyses to identify trends, signals, and potential product quality or safety issues.

• Apply SPC methodologies to monitor product and process performance.

• Support complaint trending, signal detection, and safety monitoring activities.

• Develop and maintain Power BI dashboards and data visualization tools.

• Query, integrate, and analyze data from relational databases using SQL.

• Develop analytical workflows, scripts, and tools using Python and/or R.

• Support risk management activities using post-market, complaint, and quality data.

• Interpret complex datasets and develop analytical outputs for quality and post-market surveillance activities.

• Develop and improve automated data analysis, reporting, and surveillance processes.

• Evaluate and apply machine learning methods to post-market surveillance and quality datasets where appropriate.

• Establish and maintain analytical metrics, reporting methodologies, and surveillance documentation.

• Support development and improvement of analytical tools used for post-market monitoring and risk evaluation.

Pay: 65-75/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $65.00 to $75.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.