Quality Engineer III

TALENT Software Services; Maple Grove (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

TALENT Software Services seeks a senior Quality Engineer to develop and maintain quality engineering methodologies that meet regulatory requirements and customer expectations. The role focuses on CAPA, post-market surveillance, and design/ supplier quality within medical devices.

Responsibilities include leading cross-functional quality initiatives, mentoring engineers, and implementing robust process controls to ensure compliant, high-quality products across development and manufacturing stages.

Qualifications

• 5+ years with a BS degree; 3–4 years with an MS degree.
• Medical device experience required.
• Experience owning CAPA and post-market surveillance activities preferred.
• Ability to take direction and work independently.

Responsibilities

• Provides leadership in engineering initiatives across departments.
• Coaches and mentors engineering personnel.
• Identifies and implements best-in-class Quality Engineering practices.
• Supports design changes and supplier quality activities; CAPA ownership.
• Ensures quality systems, processes, and CAPA align with internal and external requirements.

Skills

CAPA ownership

Root cause analysis

Quality systems

Leadership

Education

BS in Biomedical/Mechanical Eng

MS in Biomedical/Quality Eng

Job description

Job Purpose

Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet CLIENT, 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.

Description: Onsite - Arbor Lakes, MG

Job Purpose

Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet CLIENT, 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 include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

Key Responsibilities

• Provides a 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.
• Mentors for technical guidance in 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.
• Assures the development and execution of streamlined business systems that effectively identify and resolve quality issues.

Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance with quality requirements.

Qualifications

5+Years with BS, 3- 4 years with MS

Ability to take work direction and work independently

Medical device experience

Primary work assignments will involve supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories- authoring post-market surveillance reports, periodic document reviews, CAPA coordination and ownership, communicating with the contract manufacturer and CLIENT Quality/operations/design teams, supporting design change activities and supplier corrective records, etc.

PPost-marketsurveillance experience

Experience owning CAPA

Root cause analysis experience

Preferred

Someone with 5+ years of experience in medical devices