Quality Assurance Specialist
2 weeks ago
Job Title: Quality Assurance Specialist
Location: Holdrege, Nebraska
Job Summary: We are seeking a Quality Assurance Specialist to support our sustaining activities through the application of Quality Engineering skills for medical devices.
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 Branding project 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.
- Apply moderate level application of technical principles, theories, concepts, techniques, and quality sciences/tools.
- 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.
- Establish 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 in order 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.
Requirements:
- B.S. degree Required.
- 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
- 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.
Benefits:
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly epayroll
- Employee Discount Programs
- Referral Bonus Programs
About Yoh: Yoh is a global staffing company with over 65 years of experience in the U.S., UK, and Canada. We offer a range of benefits and opportunities for career growth and development.
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