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embecta · 2 hours ago

Quality Engineer II

Holdrege, NE

Full-time

Onsite

Mid Level

3+ years exp

Embecta is a global diabetes care company that empowers people with diabetes through innovative solutions. The Quality Engineer II will support new product development and product sustaining activities, ensuring compliance with quality standards and regulatory requirements.

DiabetesHealth CareMedical

H1B Sponsor Likely

Responsibilities

Support the plant on assigned product initiatives with technical expertise and determine associated resource needs to accomplish project goals

Provide critical quality engineering direction to Project Pearl with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans

Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences / tools

Develops solutions to routine problems of moderate scope

Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles. Make basic procedural updates

Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements

Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects

Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects

Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures

Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement

Qualification

Quality EngineeringValidationStatistical AnalysisMinitabSix Sigma CertificationASQ CQE21CFR820 KnowledgeProject ManagementInterpersonal SkillsWritten CommunicationVerbal Communication

Required

B.S. degree in Engineering (Industrial, Mechanic) or similar

3+ Years Quality experience including Validation and Quality Engineering responsibilities

Demonstrate success with statistical and problem-solving methodologies

Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices

Proficient with Minitab or other statistical software, MS Word, Excel, and MS project

Preferred

Strong understanding of failure analysis, test methods and engineering tolerances

Strong verbal, written and interpersonal skills

Six Sigma Certification Desired

ASQ CQE

Working knowledge of 21CFR820, 21CFR210 & 21CFR211 ISO 13485

Project Management experience

Certified Quality Engineer and Certified Quality Auditor (preferred)

Benefits

Competitive pay

Benefits

Continuous learning

Recognition

Career growth

Life balance components

Company

embecta

Embecta is a provider of diabetes healthcare services.

Founded in 2022

Franklin Lakes, New Jersey, USA

1001-5000 employees

https://www.embecta.com

H1B Sponsorship

embecta has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (2)