Senior Quality Engineer
Charlotte, South
Medical Device Manufacturing
$110,000 - $130,000
Start date: ASAP
I’m working with a medical device manufacturing company who are on the lookout for a Senior Quality Engineer 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.
Responsibilities:
· Set detailed guidelines for inspection and testing requirements.
· Ensure products meet company and industry quality standards.
· Develop inspection methods to analyze product quality.
· Identify and lead CAPA and process improvement initiatives.
· Develop, maintain, and monitor measurement processes to comply with ISO and FDA regulations.
· Collaborate with suppliers to investigate root causes and corrective actions for raw material or component deficiencies.
· Monitor and evaluate supplier processes for compliance with purchase orders and engineering requirements.
· Use variation management tools and techniques with select suppliers to mitigate risk.
· Audit suppliers and establish quality requirements for them.
· Report on supplier trends for management review and notify management of identified trends.
· Design and implement methods for process control, process improvement, testing, and inspection.
· Establish and maintain process flow diagrams, workplace layouts, FMEAs, and standardized work instructions.
· Perform other duties as assigned.
Requirements:
· Bachelor’s degree in engineering or a related field; Master’s degree preferred.
· 3-7 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.
· In-depth knowledge of ISO13485, ISO14971, and CFR Part 820.
· Good understanding of medical device regulations and international standards.
· Strong computer skills, especially in MS Office.
· Ability to recognize and manage projects.
· 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.
· ASQ Lead Auditor or equivalent training in auditing.
· A team player who can also work independently.
If you feel like you would be a good fit for this position, please apply for the role for immediate consideration.
Job Type: Full-time
Pay: $110,000.00 - $130,000.00 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)
- ISO13485: 1 year (Required)
- ISO14971: 1 year (Required)
- Medical Device: 1 year (Required)
Ability to Commute:
- Monroe, NC 28110 (Required)
Work Location: In person