| Company: | ACTALENT |
|---|---|
| Job Role: | Quality Engineer. |
| Experience: | (2-3 years). |
| Vacancy: | 15+ |
| Qualification: | Bachelor’s degree in Mechanical, Manufacturing, Bio, Industrial Engineering, or a related field. |
| Location: | Longmont - Colorado - USA. |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
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Job Description
The Process/Manufacturing/Quality Engineer will be responsible for ensuring that all manufacturing processes meet the stringent quality standards required for Class III medical devices. This role involves developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory requirements and industry standards. The main focus will be reporting directly with the OEM and solely reporting to their HQ's leadership team on the quality assurance that is mandated.
Responsibilities
- Develop and implement process validation protocols and reports (IQ, OQ, PQ) to ensure manufacturing processes are capable and compliant.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address process-related quality issues.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure product quality and compliance.
- Monitor and analyze process performance data to identify trends and areas for improvement.
- Lead process improvement initiatives to enhance product quality, reduce waste, and increase efficiency.
- Ensure compliance with FDA regulations and other applicable standards.
- Participate in internal and external audits, providing necessary documentation and support.
- Train and mentor production staff on quality standards and best practices.
Essential Skills
- Process Improvement
- Manufacturing process
- Continuous Improvement
- Lean manufacturing
- Six Sigma
- Process engineering
- Manufacturing engineering
- Quality engineering
- Validation
- Quality assurance
- Quality improvement
- Quality management system
- Manufacturing quality
Additional Skills & Qualifications
- Bachelor’s degree in Mechanical, Manufacturing, Bio, Industrial Engineering, or a related field.
- Minimum of 5 years of experience in manufacturing engineering, preferably in the medical device industry (high volume manufacturing).
- Lean Six Sigma certification is highly desirable.
- High quality documentation standards knowledge.
- Hands-on floor work ability.
Pay and Benefits
The pay range for this position is $50.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Join Our What'sApp Groups Click Here
How to Apply Click on the Below link, it will redirect you to source Page and apply there.
How to Apply Click on the Below link, it will redirect you to source Page and apply there.
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