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Boston Scientific · 1 day ago

Quality Engineer II

Maple Grove, MN

Full-time

Onsite

Entry, Mid Level

$72K/yr - $136K/yr

2+ years exp

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Quality Engineer II role focuses on developing and maintaining quality engineering methodologies to meet regulatory requirements and improve quality initiatives within the organization.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Collaborate with technicians and manufacturing engineers in assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. May be responsible for working to bound product and document release criteria

Uses risk analysis tools, including but not limited to, hazard analyses, DFMEA, PRA, to evaluate and disposition product quality issues

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

Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects

Leads 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

Acts as team member in supporting quality disciplines, decisions, and practices

Participates in team decision making and displays team problem solving/communication skills

Working with Project Management and Division teams to support new and updated products added to the area

Process ownership

Proactively investigates, identifies, and implements best-in-class Quality Engineering practices

Provide support and mentorship to area Quality Technicians

Qualification

Quality EngineeringRisk AnalysisProcess ValidationStatistical SamplingRoot Cause InvestigationQuality System RegulationsProblem SolvingCollaborationCommunicationMentorship

Required

Bachelor's degree in engineering or science related field

Minimum 2 years experience in an engineering or science related field

Preferred

Experience in a regulated medical device industry, preferably in Quality

Experience in an operations setting

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

Prior experience with non-conforming material review process

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.)

Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards