Quality Engineer

About the role

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Functional Engineering Roles

• Design Assurance
• Operations Quality
• Software Engineering
• Supplier Assurance
• Product Analysis
• Metrology
• Microbiologist
• Chemist

Responsibilities

• Provide leadership on departmental or cross‑functional engineering initiatives.
• Offer project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigate, identify, and implement best‑in‑class Quality Engineering practices.
• Mentor technical staff in identifying and resolving quality issues.
• Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Act as an effective leader or team member supporting quality disciplines, decisions, and practices.
• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Assure development and execution of streamlined business systems that effectively identify and resolve quality issues.

Requirements

• 5+ years of experience with a BS degree, or 3–4 years with an MS degree.
• Ability to take work direction and work independently.
• Medical device experience, including coordination and ownership of activities with contract manufacturers and BSC Quality/Operations/Design teams.
• Experience supporting design change activities and supplier corrective records.
• CAPA experience, including authoring post‑market surveillance reports and periodic document reviews.
• Experience owning CAPA root‑cause analysis.
• Support of Quality systems and operations for hepatic artery infusion pump and accessories.