Quality Engineer

1710 embecta Medical I LLC; Holdrege (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

embecta is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices. You will work with quality management, operations, suppliers, and embecta associates to ensure compliance with quality policies, design controls, and regulatory requirements throughout product lifecycle.

Responsibilities include applying quality engineering tools (RCA, FMEA, validation, DOE), contributing to continuous improvement, and coordinating validation and change

Qualifications

• B.S. degree in Engineering (Industrial, Mechanical) or similar.
• 3+ years of quality experience including validation and quality engineering responsibilities.
• Certified Quality Engineer and Certified Quality Auditor (preferred).

Responsibilities

• Support the plant on assigned product initiatives with technical expertise and determine resource needs to accomplish goals.
• Provide critical quality engineering direction with RCAs, FMEAs, risk mitigation, validation, and DOE/tools.
• Apply a moderate level of technical principles and quality sciences/tools.
• Develop solutions to routine problems of moderate scope.
• Maintain alignment to quality policies and practices through sound QA principles.

Skills

Root cause analysis

FMEA

Risk mitigation

Validation

DOE

Process improvement

Measurement systems analysis

MS Office

Statistical methods

Project management

Education

B.S. in Engineering (Industrial or Mechanical)

Tools

Minitab

MS Word

Excel

MS Project

Job description

Overview

emBecta is a global medical device company with a 100‑year legacy in insulin delivery and diabetes care. 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.

SUMMARY As directed by the Quality Engineering Manager, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. 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.

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 and principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
• Apply a moderate level of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Develop 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.
• Demonstrate working knowledge of applicable regulatory, Corporate and/or Unit requirements.
• Act as an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.
• Establish a strong working relationship with all levels of operations to monitor and analyze in‑process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to lead identification and documentation of continuous improvement projects.
• Approve protocols and reports for all validation and change control activities to ensure compliance with established procedures.
• Utilize Lean and Six Sigma problem‑solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.

Experience & Education

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

Knowledge, Skills and Abilities

• Demonstrate success with statistical and problem‑solving methodologies.
• Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation processes 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.
• ASQ CQE.
• Working knowledge of 21CFR820, ISO 13485.
• Project Management experience.

EEO Statement

embecta is an Equal Opportunity/Affirmative Action Employer. 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 orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At embecta, a career is more than a job; it is an opportunity to make a meaningful difference in the lives of about 30 million people around the world who depend on our products to manage a chronic condition every single day. As we expand our capabilities, reach, and impact, there’s never been a more exciting time to join us.