Embecta

Quality Engineer

USA NE - Holdrege

Sponsorship not specifiedDetected 4 hours ago

Data AnalysisProject ManagementExcelProcess ImprovementMedical DevicesProblem Solving

About the role

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care.
For Sustaining Product activities, this person will understand, improve, and control operational processes to realize predictable product flow while satisfying established embecta standards of quality.
Successful performance requires close work with quality management, operations, suppliers and/or embecta associates to assure compliance with all embecta quality policies, procedures, and practices.

§ Support the plant on assigned product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
§ 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.
§ 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.
§ Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
§ Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.

§ B.S. degree in Engineering (Industrial, Mechanic) or similar
§ 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
§ Certified Quality Engineer and Certified Quality Auditor (preferred).

§ 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.
§ Strong understanding of failure analysis, test methods and engineering tolerances.
§ Strong verbal, written and interpersonal skills.
§ Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
§ Six Sigma Certification Desired.
§ Working knowledge of 21CFR820, ISO 13485.
§ Project Management experience.
embecta is an Equal Opportunity/Affirmative Action Employer.

Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o

This listing is sourced directly from Embecta's careers page and normalized into a canonical job model.