This is NOT C2C but W-2 ONLY.
Medical Device Experience Required
$40 per hour - 2 year contract
Benefits offered through agency
Onsite role ONLY
JOB TITLE:
Validation Quality Engineer
LOCATION:
Holdrege, Nebraska
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:
EDUCATION
* B.S. degree Required.
o B.S. degree in Engineering (Industrial, Mechanic) Desired
EXPERIENCE
* 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.
Future Yoh Contractors - Here's who we are and what offer you:
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK, and Canada.
Join Yoh's extensive talent community and that will provide you with access to Yoh's vast network of opportunities. Gain access to this exclusive opportunity available to you.
Benefits offered:
Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly epayroll
- Employee Discount Programs
- Referral Bonus Programs
Apply today and speak with a recruiter!!
Senior Recruiter - Yoh Services
Yoh.com
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit
https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
YOH Services LLC
401(k), employee discount
Nov 16, 2024