myGwork - LGBTQ+ Business Community · 3 days ago

Quality Engineer II

Arden Hills, MN

Full-time

Onsite

Entry, Mid Level

2+ years exp

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Responsibilities

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

Collaborate with technicians and manufacturing engineers in assisting in the identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material.

Use risk analysis tools to evaluate and disposition product quality issues.

Perform process validation and verification activities, including test method validation, and generate/review related documentation.

Identify possible sources of manufacturing defects and devise methods to reduce process variation to reduce/eliminate the cause of defects.

Lead process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.

Act as a team member in supporting quality disciplines, decisions, and practices.

Participate in team decision-making and display team problem-solving/communication skills.

Proactively investigate, identify, and implement best-in-class Quality Engineering practices.

Provide support and mentorship to area Quality Technicians.

Qualification

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Regulated medical device industryNon-conforming material review processTest method validation methodologiesMinimum 2 years experienceMoldingSilicone MaterialsManufacturing EngineeringPost Market ComplaintsCAPARisk ManagementSupplier QualityProcess EngineeringValidationStatistical SamplingRoot Cause InvestigationProduct DocumentationInspectionTestingManufacturing ExecutionGreen BeltCQESix SigmaProblem Solving

Required

Bachelor’s degree in engineering or science related field

Experience in a regulated medical device industry

Prior experience with non-conforming material review process

Basic understanding of test method validation methodologies

Minimum 2 years experience

Preferred

Experience in molding and silicone related materials

Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering

Experience in Validation, Statistical sampling and/or Root Cause Investigation

Familiarity with product documentation, inspection and testing, and Manufacturing Execution

Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.)