Quality Engineer

RXinsider LTD.; Holdrege (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

embecta is a global medical device company with a long history in insulin delivery and diabetes care. The Quality Engineer II role supports new product development and sustaining activities, ensuring design controls, regulatory compliance, and quality systems are met.

The position emphasizes collaboration with quality, operations, suppliers and R&D to drive robust product quality. As a member of the Site Quality team, you will apply statistical tools, risk assessment, and validation methods to

Qualifications

• 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).

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 with respect to root cause analysis, FMEAs, risk mitigation, validation, DOE and other process-improvement tools.
• Apply moderate level application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Develop solutions to routine problems of moderate scope.
• Maintain alignment to quality policies and procedures through sound QA principles.
• Demonstrate working knowledge of regulatory, corporate and unit requirements.
• Represent Site Quality on development and sustaining projects.
• Monitor and analyze in-process inspection, process control, waste, and customer complaints to drive improvements.
• Approve protocols and reports for validation and change control activities.
• Use Lean and Six Sigma problem solving methods to support validation and continuous improvement.

Skills

Statistical methods

Quality engineering

Failure analysis

Communication skills

Minitab

MS Word

MS Excel

MS Project

Six Sigma

ASQ CQE

ISO 13485 knowledge

21CFR820 knowledge

Project management

Education

B.S. in Engineering (Industrial/Mechanical)

CQE certification

CQA certification

Tools

MS Project

Minitab

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, anda commitmentto improving lives, we are expanding our portfolio of solutions to serve even morepatients, healthcare providers, and communities around the world.

SUMMARY JOB DESCRIPTION:

As directed by the Quality Engineering Manager, 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/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.

EXPERIENCE & EDUCATION:

• 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).

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 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.
• ASQ CQE
• Working knowledge of 21CFR820, ISO 13485.
• Project Management experience.

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.