Quality Engineer Medical Device

Job Description

Job Description

Title: Quality Engineer (Medical Device)

Location: Maple Grove, MN, 55311

Duration/Type: Contract to hire - 9 Months

Job Purpose
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, 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.

Key Responsibilities

• Provides leadership role in 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.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Leads in the 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 sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Qualifications

• 4-6 Years of experience with a BS in Engineering. The degree must be stated on the resume.
• 2-3 Years with MS (no restriction on MS degree)
• Experience in CAPA systems
• Design controls
• Process controls
• Must have experience in a regulated environment. Must be clear on the resume.