Quality Engineer II
Charlotte, South
Medical Device Manufacturing
$90,000 - $110,000
Start date: ASAP
I’m working with a medical device manufacturing company who are on the lookout for a quality engineer II to join their team in South Charlotte North Carolina.
This is a medium sized manufacturing company, but they are investing heavily in their staff and their infrastructure to be able to grow into a well-known household brand.
This company already has a global presence and works with a wide array of clients themselves. These vary from small startups to some of the biggest names in the world, and you could be a part of this growing company.
If you want to become a part of a team that invests in it’s staff to improve the overall company, that has clear paths of progression to promotions and a company that has committed to an impressive amount of growth in the next 5 years then this could be the company for you.
Job responsibilities:
· Develop, maintain, and monitor quality processes to meet ISO and FDA regulations.
· Represent quality in new product and process development, including evaluating technical drawings, test methods, and validations.
· Lead non-conformance investigations with other departments to identify root causes and properly handle nonconforming products.
· Present findings from trend reviews or nonconformances to the team and management.
· Write technical reports on nonconformance and complaint investigations, as well as effectiveness reports for completed CAPAs.
· Conduct risk assessments like pFMEA to identify product risks and determine material concessions through the Material Review Board.
· Help improve quality using statistical methods and lead improvement projects for safety, quality, and productivity.
· Represent quality in change control processes, validation, and continuous improvement activities for Production and Quality Control departments.
· Analyze quality trends and report them to management, escalating issues when needed.
· Create, review, and approve fixture designs and prototypes.
· Monitor the effectiveness of employee training for inspection processes.
· Write SOPs, test procedures, validation protocols, and reports.
· Conduct engineering studies using scientific principles.
· Perform tasks accurately and with great attention to detail.
· Perform other duties as assigned
Role requirements:
· Bachelor’s degree in engineering or a related field.
· 2-5 years of experience in high-volume, regulated manufacturing.
· Experience with Six Sigma, lean, and Quality Management Tools.
· Strong understanding of statistics and statistical process control.
· Proficient with Access Database, Excel, and complaint handling software.
· Basic knowledge of medical device regulations and international standards.
· Strong computer skills, including QA applications, word processing, spreadsheets, and databases.
· Skilled at identifying problems, collecting data, and drawing conclusions.
· Able to read and understand technical drawings and documents.
· Experience with CAD/SolidWorks.
· Able to work independently and take initiative.
· Excellent communication, analytical, troubleshooting, and interpersonal skills.
· A team player who can also work independently.
If you feel like you have the experience required please apply for the role for immediate consideration.
Job Type: Full-time
Pay: $90,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
Schedule:
Education:
Experience:
- Quality Engineering: 3 years (Required)
- CAD/Solidworks: 1 year (Required)
- CGMP: 1 year (Required)
Ability to Commute:
- Monroe, NC 28110 (Required)
Work Location: In person