Quality Engineer

Lumicity; California (MO); On-site; USD 80,000 - 97,500; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

Join a thriving medical device company as a Recruitment Consultant focused on quality assurance. This full-time role offers the opportunity to develop and maintain risk management files while collaborating with cross-functional teams to tackle quality challenges. You'll play a crucial role in evaluating product quality risks and improving processes to enhance speed and cost-effectiveness. The company is committed to innovation in the medical equipment sector and seeks individuals who are passionate about making a difference. If you're ready to take your career to the next level in a supportive environment, this position is for you.

Qualifications

• Minimum 1.5 years of experience in medical device engineering.
• Knowledge of ISO 14971, FDA QSR, and ISO 13485.

Responsibilities

• Develop and maintain risk management files and validation plans.
• Collaborate with teams to solve quality problems and manage risks.

Skills

Statistical Analysis

Project Management

Communication Skills

Risk Management

Business Process Development

Education

BS in Engineering

Tools

Microsoft Office

Job description

Recruitment Consultant at Lumicity | Life Sciences | Senior and Executive Positions

This full-time position is with a thriving medical device company looking to expand their quality assurance department! Please see details below:

Job Duties/Responsibilities:

• Develop and maintain risk management files, including FMEAs.
• Create and manage master validation plans, test method validations, and equipment/process qualifications.
• Collaborate with cross-functional teams to solve quality problems.
• Evaluate product quality risks and manage nonconforming materials.
• Provide investigative support for product quality issues and corrective actions.
• Develop new processes to improve speed, cost, and quality.
• Perform statistical analysis for root cause analysis and process control.

Qualifications:

• BS in Engineering or relevant experience in medical devices.
• Minimum 1.5 years of experience in medical device engineering.
• Experience with business process development and statistical analysis.
• Knowledge of risk management, ISO 14971, FDA QSR 21 CFR Part 820, and ISO 13485.
• Lean Six Sigma Certification preferred.
• Strong project management and communication skills.
• Proficiency in Microsoft Office and ability to travel/work flexibly.

Looking for candidates who are willing and able to work or relocate to Central California. US Citizens only. Get in touch or refer a peer!

Base pay range

$80,000.00/yr - $97,500.00/yr

Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Medical Equipment Manufacturing

Benefits:

• Medical insurance
• Vision insurance
• 401(k)