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Quality Engineer II

1 month ago

Maple Grove, United States Careerbuilder-US Full time

Job Title: Quality Engineer II

Location: Maple Grove, MN 55311

Duration: 6 Months+ - Hybrid (3 days a week)

Job Description:

• Candidates need to have Design Assurance experience.

Job Purpose

· Design Assurance Engineer develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, 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.

Key Responsibilities:

· Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

· Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

· Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements.

· Develop Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

· Create and maintain product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs).

· Support test method development and test method validation activities.

Minimum qualifications:

• Bachelor’s degree in engineering discipline or related field of study

• 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry

• Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations

• Effectively work and collaborate in a hybrid (onsite plus remote) environment