Job Title: Quality Engineer (Cleanroom and Non-Cleanroom)

For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Job Description

We are seeking a dedicated Quality Engineer to join our team. The ideal candidate will be responsible for ensuring the highest quality standards in both cleanroom and non-cleanroom environments. This role involves implementing quality control plans, improving manufacturing processes, and collaborating with various departments to maintain product excellence.

Responsibilities

• Implement and maintain quality control plans and procedures to ensure products meet standards.
• Identify areas for improvement in manufacturing processes and implement solutions to enhance quality and efficiency.
• Investigate and resolve quality issues, including root cause analysis, corrective actions, and preventive measures.
• Maintain accurate records of quality data, inspection results, and corrective actions.
• Collaborate with engineering, manufacturing, and suppliers to ensure quality throughout the product lifecycle.
• Ensure compliance with relevant regulations and standards, such as FDA guidelines.
• Work with suppliers to ensure they meet quality standards and implement corrective actions for any issues.
• Assist in the development and validation of new products to ensure they meet quality and regulatory requirements.
• Review and deliver First Article Inspections for sustaining parts and development projects.
• Develop and implement validation strategies for manufacturing processes to ensure they meet quality standards.
• Develop methods and procedures for process control, improvement, testing, and inspection to ensure products are free of flaws and function as designed.
• Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels.
• Analyze reports and defective products to determine trends and recommend corrective actions.
• Support production in cleanroom and non-cleanroom environments, including work instruction development, process validation, quarantine/MRB, and daily management.

Essential Skills

• Quality engineering
• Quality assurance
• Process validation
• Production quality control
• Knowledge of ISO quality management systems
• Experience in a manufacturing environment, preferably in a medical device or pharmaceutical setting
• 1-2 years of experience for Level I and 3-5 years of experience for Level II
• Strong analytical, problem-solving, and communication skills

Additional Skills & Qualifications

• Bachelor's degree in engineering, science, or a related field
• Certifications such as Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt may be preferred
• Ability to work independently with minimal supervision
• Experience supporting production in cleanroom environments

Work Environment

Onsite in a cleanroom or production environment. Benefits include 2 weeks PTO and 10 paid holidays.