Senior Quality Engineer - Combination Product
About The Position
Boston Scientific is seeking a Senior Quality Engineer to support manufacturing of combination products, partnering with Operations and Product Development to ensure compliance with current Good Manufacturing Practice (cGMP) requirements while delivering high-quality drug-device combination therapies. The role directly supports the Arden Hills Operations business unit manufacturing Urology combination products and may collaborate with other business units, product portfolios, and divisions. The position is based on-site at the Arden Hills facility five days per week. Boston Scientific is not offering employment visa sponsorship or relocation assistance for this position.
Requirements
- Bachelor's degree or higher in Chemical Engineering, Chemistry, or a related scientific or engineering discipline.
- At least 5 years of experience in manufacturing, quality engineering, regulatory work, or a related regulated industry.
- At least 2 years of experience supporting regulated cGMP environments involving combination products under 21 CFR Part 4 and/or pharmaceutical manufacturing under 21 CFR Parts 210 and 211.
- Demonstrated experience supporting cGMP compliance for drug-device combination products or pharmaceutical manufacturing.
- Knowledge of statistical analysis methods and proficiency with Microsoft Excel and Minitab.
- Demonstrated experience supporting internal and external quality audits.
Nice To Haves
- At least 7 years of experience in manufacturing, quality, or regulatory functions.
- At least 2 years of 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.
Responsibilities
- Lead compliance and continuous improvement initiatives for combination product manufacturing 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, and implement corrective and preventive actions.
- Develop quality tools and training materials, and communicate requirements across a broad range of organizational skill levels.
- Lead cross-functional teams in reducing manufacturing defects, scrap, nonconforming product, and customer complaints through root cause analysis and corrective actions.
- Support product containment activities, including product stops and documentation of release criteria, as required.
- Develop and implement product quality plans, specifications, risk analyses, and Failure Modes and Effects Analyses (FMEAs) 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 quality systems, manufacturing operations, and business practices for effectiveness and compliance with applicable regulations and internal procedures.
- Perform internal quality audits as assigned and support continuous improvement of the Boston Scientific Quality System.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
