Quality Engineer II

Quality Engineer II

At Boston Scientific, the Quality Engineer II will provide direct Quality Engineering support to ensure manufacturing and delivery of the highest quality product to our customers and patients.

In a fast-paced and dynamic environment, the Quality Engineer II is responsible for manufacturing line processes, partnering cross-functionally with product and process development, manufacturing engineering, and production teams to achieve business unit goals.

In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your Responsibilities Include:

• Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
• Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
• Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
• Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
• Provide task direction, coaching, and mentorship for technician team members.
• Participate in team decision-making and display team problem-solving/communication skills.

What We're Looking For: Required Qualifications:

• Bachelor's degree in engineering, technology, mathematics, or related science
• 2+ years of relevant experience in a regulated industry
• Strong verbal and written communications skills; Good documentation practices
• Works effectively in a Controlled Environment Area (CEA) manufacturing environment
• Self-starter with a proven ability to successfully work with minimal supervision
• Knowledge of basic Quality Management Systems
• Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications:

• Medical device experience
• Comfortable with utilizing analytical equipment (including microscopes)
• Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
• Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
• Experience running/owning nonconforming event risk assessments and investigations
• Proficient using manufacturing control software (various MES, MasterControl, etc.)
• Project management experience