Senior Quality Engineer - Combination Product

About the role

At this time, we are seeking a Senior Quality Engineer to support the manufacturing of combination products. In this role, you will partner with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practice (cGMP) requirements for combination products while delivering innovative, high-quality drug-device combination therapies for patients. This position directly supports the Arden Hills Operations business unit manufacturing Urology combination products and offers opportunities to collaborate across additional business units, product portfolios, and divisions.

Your responsibilities will include

• Lead compliance and continuous improvement initiatives supporting the manufacture of combination products in accordance with 21 CFR Part 4.
• Serve as the technical quality lead during internal and external audits related to combination product compliance.
• Analyze quality data to identify trends, drive continuous improvement initiatives, and implement effective corrective and preventive actions.
• Develop quality tools and training materials while effectively communicating requirements across a broad range of organizational skill levels.
• Lead cross-functional teams to reduce manufacturing defects, including scrap, nonconforming product and customer complaints, through root cause analysis and corrective actions.
• Support product containment activities, including product stops and release criteria documentation, as required.
• Develop and implement product quality plans, specifications, risk analyses and Failure Modes and Effects Analyses (FMEAs) in partnership with Product Development and Manufacturing teams.
• Develop process monitoring systems by identifying critical manufacturing process steps, reducing process variation and improving process capability.
• Collect, analyze and interpret manufacturing quality metrics to support sustaining product improvements and new product development initiatives.
• Evaluate the effectiveness and compliance of quality systems, manufacturing operations and business practices against applicable regulations and internal procedures.
• Perform internal quality audits, as assigned, and support continuous improvement of the Boston Scientific Quality System.

Required qualifications

• Minimum Bachelor's degree in Chemical Engineering, Chemistry or a related scientific or engineering discipline.
• Minimum of 5 years' experience in manufacturing, quality engineering, regulatory or a related regulated industry.
• Minimum of 2 years' experience supporting regulated cGMP environments involving combination products (21 CFR Part 4) and/or pharmaceutical manufacturing (21 CFR Parts 210 and 211).
• Demonstrated experience supporting cGMP compliance for drug-device combination products or pharmaceutical manufacturing.
• Proven knowledge of statistical analysis methods and proficiency with Microsoft Excel and Minitab.
• Demonstrated experience supporting internal and external quality audits.

Preferred qualifications

• Minimum of 7 years' experience in manufacturing, quality or regulatory functions.
• Minimum of 2 years' experience providing technical leadership.
• Experience managing multiple cross-functional projects simultaneously.
• Recent or current experience serving as a technical lead during external regulatory audits.
• Demonstrated commitment to proactive quality, regulatory compliance and continuous improvement.