Senior Quality Engineer

Senior Quality Engineer

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

The Packaging, Sterilization and Men's Health team within Arden Hills Operations is seeking a Senior Quality Engineer to develop, implement and maintain quality engineering systems, methodologies and practices that ensure compliance with Boston Scientific, customer and regulatory requirements.

As a key quality representative, you will provide technical leadership and partner across functions to drive quality initiatives that support operational excellence, product quality and business objectives. You will play a critical role in process validation, risk management, process controls and continuous improvement efforts, ensuring products consistently meet internal and external requirements throughout the product life cycle. Working in a collaborative environment, you will lead quality engineering projects, mentor technical team members and apply data-driven problem-solving approaches to identify, resolve and prevent quality issues while strengthening manufacturing processes and quality system effectiveness.

Your responsibilities will include:

• Select appropriate techniques for problem-solving and make sound, consistent engineering and quality assurance recommendations.
• Read and interpret technical drawings, procedures and protocols.
• Exercise independent authority to make decisions related to product quality, including the disposition of nonconforming product.
• Identify manufacturing process defects, including scrap, nonconforming material and customer complaints, by dispositioning nonconforming material, assisting with root cause identification and supporting corrective and preventive actions. Partner with process owners to define product holds and document release criteria as needed.
• Participate in customer complaint investigations for assigned manufacturing areas.
• Support the execution and investigation of corrective and preventive actions (CAPAs), nonconforming events, failure mode investigations and related quality system activities.
• Demonstrate and promote the highest standards of quality engineering discipline and technical rigor.
• Serve as a quality systems resource by promoting compliance with Quality System Regulation (QSR), ISO standards and applicable medical device regulations while escalating critical quality decisions to Quality Engineering leadership when appropriate.
• Apply advanced validation engineering expertise while ensuring compliance with applicable regulatory requirements.
• Review and approve operational, test and validation data to establish technical specifications and performance standards for new or modified products and processes.
• Champion continuous improvement and innovation from a quality perspective throughout the product life cycle, from supplier qualification through customer satisfaction.
• Provide technical guidance and mentorship to Quality Engineers, Associate Quality Engineers, technicians and inspection personnel.
• Partner with Environmental Health and Safety to identify significant environmental impacts and support goals and objectives that improve environmental performance.
• Collaborate with suppliers, manufacturing, engineering and cross-functional partners to resolve quality issues and drive operational excellence.
• Support internal quality audits and maintain audit readiness.

Qualifications:

Required qualifications:

• Bachelor's degree or higher, preferably in an engineering discipline.
• Minimum of 9 years' experience in operations quality.
• Strong understanding of quality operations fundamentals, regulatory requirements and quality systems.
• Experience working in regulated manufacturing environments.
• Experience with product risk assessment.
• Experience performing root cause analysis and implementing corrective and preventive actions.
• Experience with CAPA, nonconforming event and failure mode investigations.
• Experience with validation engineering and process validation.
• Knowledge of Quality System Regulation (QSR), ISO standards and medical device regulations.
• Experience reviewing operational, test and validation data to establish technical specifications and performance standards.
• Strong analytical and decision-making skills with the ability to solve complex quality issues.
• Excellent communication and cross-functional collaboration skills.
• Experience conducting customer complaint investigations.

Preferred qualifications:

• Experience in the medical device industry.
• Experience using data analysis to identify trends, determine root causes and implement effective solutions.
• Demonstrated ability to influence stakeholders and lead quality initiatives across cross-functional teams.
• Experience mentoring technical team members and providing engineering guidance.