Quality Engineer I - Medical Devices

Medical Murray
Title:Quality Engineer I
Location: Charlotte, NC (*Onsite position)
Some relocation assistance may be available

Due to continuous growth, we are searching for an experienced medical device Quality Engineer. Within the Medical Murray Engineering team, you will have a hands-on role in product development designing, and producing our clients' Medical Devices. Our environment will offer a varied day with direct interaction with our clients in discussing assigned projects, next steps, and fielding our clients' questions. Working collaboratively with the Medical Murray team in a high-energy environment, you will work on leading-edge technology as you roll out new Medical Devices to market. Combining best-in-class design, development, and manufacturing expertise, 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!
About Medical Murray:
Since 1996, Medical Murray has been a privately owned company producing finished Medical Devices, components, and subassemblies for customers around the world ranging from startups to the largest OEMs. We specialize in the development, testing, and manufacturing of permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our core goals are Integrity First, People Matter, First Class Service, Inspired Innovation, and Community Service. To learn more, please visit us at www.medicalmurray.com.

Position Summary:

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

Minimum Qualifications:

• BS or MS in Biomedical or Manufacturing Engineering
• Six Sigma Green Belt desired
• Quality assessment/audit experience is desirable
• 3 years of experience in Quality Engineering for Medical Devices
• Experience in the area(s) of ISO and FDA Quality Systems

Knowledge, Skills, Abilities:

• Advanced knowledge and understanding of ISO-13485 and FDA 21 CFR Part 820 cGMP standards.
• Technical skills must include medical device testing, protocol writing, and report writing.
• Knowledge of statistics, for example, experiment design and SPC
• Computer skills needed include Microsoft Office or equivalent
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills

Essential Duties and Responsibilities:

• Responsible to follow Medical Murray Quality system, including all applicable SOPs included in the Training Matrix
• Supervise and perform testing and inspection activities, including training of inspectors or technicians
• Maintenance and support of inspection records
• Provide quality and reliability engineering functions on product development projects (per ISO and FDA requirements)
• Lead and/or support production improvement initiatives
• Review components, products, and processes for optimization of inspection method, sampling plan, and documentation
• Train employees concerning quality standards
• Develop and document control plans that 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; and process capabilities
• Perform internal audits of the quality system and verification activities; and supplier audits as requested
• Use inspection, measuring, and test equipment as necessary
• Support sterilization systems companywide. Set up product-specific requirements and maintain Medical Murray standard cycles

For Your Benefits:

• 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

Medical Murray is an equal-opportunity employer.