Role: Quality Validation Engineer
Location: 1329 West North Avenue Holdrege NE 68949
Duration: 24 Months on W2
SUMMARY JOB DESCRIPTION:
- The Validation Engineer is responsible for execution and implementation of validation initiatives in support of Project Pearl. Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group. This position is also responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders. This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards. Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles.
RESPONSIBILITIES:
- Essential functions include but are not limited to: 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 Pear 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 Required.
- B.S. degree in Engineering (Industrial, Mechanic) Desired
- 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
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.
