Quality Engineer - Medical Devices

Job Description

Job Description

The wage range for this position is $70,000 to $90,000. Compensation decisions are dependent on the specific details and circumstances of each candidate such as experience, skills, and education. Therefore, job title and salary range may vary.

Medical Murray

Have you been dreaming of a job that combines helping people with top notch engineering? Then this job is perfect for you! Medical Murray's purpose is to help healthcare providers offer a higher quality of care, giving patients more time and a higher quality of life. If you want to be part of a team like that, please apply!

Medical Murray Offers:

• Competitive salary
• Billable overtime or can be taken as additional PTO
• Medical Insurance (BCBS): Eligible on the first day of employment
  • HSA-eligible health insurance
• Dental Insurance
• Company paid Vision, Life, and Long and Short-Term Disability insurance
• TeleDoc program
• Identity protection
• 401k safe harbor retirement plan
• 18 days of PTO
• Tuition reimbursement
• Paid time off for community outreach and volunteering
• Company paid monthly events

Position Summary:

The Quality Engineer position performs engineering duties in the quality department in support of the quality department objectives to provide goods and services that meet customer's requirements for quality, quantity and timeliness. Position's responsibilities pertain to addressing technical activities within the quality organization.

Essential Duties and Responsibilities:

• Supervise and perform testing and inspection activities, including training of inspectors or technicians
• Provide quality and reliability engineering functions on product development projects (per ISO and FDA requirements)
• Reviews components, products and processes for optimization of inspection method, sampling plan and documentation
• Train employees concerning quality standards
• Develop and document control plans which define verifications during production to ensure all stated requirements are met
• Work with production in support of validation and qualification studies
• Create, modify and implement quality systems and procedures (internal and external)
• Provide general quality support as required by management
• Analyze nonconforming conditions in production to determine root cause
• Communicate with process owners to resolve nonconforming conditions by developing or facilitating corrective and preventative actions
• Summarize and report nonconformance information and evaluate trends and major causes
• Plan and document studies of measurement repeatability and reproducibility
• Perform internal audits of the quality system and verification activities

Minimum Qualifications (Knowledge, Skills, Abilities):

• BS in engineering discipline or equivalent experience
• 3-5 years of experience in Quality Engineering for medical devices
• Experience in the area(s) of ISO and FDA Quality Systems
• Knowledge and understanding of ISO-13485 and FDA 21 CFR Part 820 cGMP standards,
• Technical skills must include disposable medical device testing, protocols, analysis and report writing, knowledge of statistics, for example experiment design and SPC
• Strong analytical and problem solving skills

Preferred Qualifications

• Six Sigma Green belt desired
• Quality assessment / audit experience is desirable

Medical Murray is an equal opportunity employer.