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

• Provides leadership on championing departmental or cross‑functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best‑in‑class Quality Engineering practices.
• Mentors technical staff in identifying and resolving quality issues.
• Identifies and implements effective process control systems to support development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Leads implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensures development and execution of streamlined business systems that effectively identify and resolve quality issues.
• Supports Quality systems and operations for the hepatic artery infusion pump and accessories, authors post‑market surveillance reports, conducts periodic document reviews, and owns CAPA root‑cause analysis activities.

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 coordinating and owning activities with contract manufacturers and BSC Quality/operations/design teams, supporting design changes and supplier corrective records.
• CAPA experience, including ownership of root‑cause analysis.
• Post‑market surveillance experience.