Quality Engineer-Onsite

Great opportunity to join a leading med device manufacturing company focusing on changing the lives of patients around the world!
This Jobot Job is hosted by: Matt Tassoni
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $110,000 per year

A bit about us:

Our client is an industry leading med device manufacturing company focusing on changing the lives of patients around the world!

Why join us?

BONUS from 5%-%10
Medical
Dental
401k
PTO
and more!!

Job Details

Job Details:
We are seeking a dynamic Permanent Quality Engineer with a passion for quality control and improvement in the Med Device Industry! This role will be instrumental in ensuring that our products and services meet and exceed the required quality standards. The successful candidate will have a firm grasp of ISO 14791, ISO 13485, 21 CFR 820, Six Sigma, SPC, Linear Regression, DOE, Process Capability and Medical Device standards. ASQ certification is a plus. This position requires a minimum of 2 years of experience in a similar role.
Responsibilities:

• Implement and manage the quality control systems in accordance with ISO 14791 and ISO 13485.
• Develop and execute test protocols for product quality verification and validation.
• Analyze data using statistical process control (SPC) and linear regression, and design experiments (DOE) to understand, improve, and control processes.
• Ensure compliance with 21 CFR 820 for all products and processes.
• Drive continuous improvement initiatives using Six Sigma methodologies.
• Evaluate process capability and implement appropriate actions to improve product quality.
• Collaborate with cross-functional teams to resolve quality issues and implement corrective and preventive actions.
• Conduct internal audits to ensure compliance with quality standards and regulations.
• Participate in regulatory inspections and audits.
• Provide quality engineering support in the design and development of medical devices.
• Prepare quality reports and documentation for management review.
• Train and mentor other team members on quality standards and procedures.

Qualifications:

• Bachelor's degree in Engineering or a related field.
• Minimum of 2 years of experience as a Quality Engineer, preferably in the legal industry.
• Strong knowledge of ISO 14791, ISO 13485, 21 CFR 820, Six Sigma, SPC, Linear Regression, DOE, Process Capability, and Medical Device standards.
• ASQ Certified Quality Engineer or equivalent is highly desirable.
• Excellent problem-solving and analytical skills.
• Proficient in statistical analysis and data interpretation.
• Strong understanding of quality control principles and methodologies.
• Excellent communication and interpersonal skills.
• Ability to work in a cross-functional team and lead quality improvement projects.
• Proficient in the use of quality control software and tools.
• Strong attention to detail and commitment to quality.
• Ability to manage multiple tasks and projects simultaneously.
• Strong knowledge of regulatory requirements in the legal industry.

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.