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Boston Scientific · 1 day ago

Quality Engineer III

Maple Grove, MN

Full-time

Onsite

Mid Level

$76K/yr - $144K/yr

3+ years exp

Boston Scientific is a leader in medical science, providing opportunities to work on significant health industry challenges. The Quality Engineer III role involves supporting quality engineering for manufacturing lines, ensuring high-quality product delivery, and engaging in continuous improvement projects.

Health CareMedicalMedical Device

No H1B

Responsibilities

Leading or participating in projects to identify root cause and implement corrective and preventive actions

Understanding nonconformance scope, implementing product/process controls, and determining release criteria

Investigating nonconformances and writing required documentation

Collecting and analyzing process defect data for product and process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing appropriate analysis

Performing process validation and verification activities and reviewing related documentation

Supporting the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements

Developing and updating risk management deliverables

Evaluating the adequacy and compliance of systems, operations, and practices against regulations and company documentation

Qualification

Process validationRisk management documentationQuality systems knowledgeStatistical analysisManufacturing support experienceCross-functional team leadershipMicrosoft Office proficiencyCommunication skillsSelf-starterProblem solvingDocumentation

Required

Bachelor of Science in Engineering

Minimum of 3 years' relevant experience, specifically involving process validation and verification activities and risk management documentation such as Design/Process FMEAs

Knowledge of basic quality systems and good documentation practices

Preferred

Strong written and verbal communication skills

Ability to work independently with limited supervision

Experience in the medical device field in a manufacturing support role

Experience providing quality support to manufacturing lines

Self-starter with the ability to identify improvement opportunities

Experience leading cross-functional teams and driving projects to completion

Demonstrated ability to manage multiple projects spanning diverse engineering disciplines (e.g., equipment qualification, process validation, test method validation)

Prior interactions with disciplines such as manufacturing engineering, CAPA, risk management, supplier quality, and process engineering

Knowledge of analytical techniques, problem solving, and statistical analysis

Proficiency with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook

Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution Systems