· 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: $90,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance

Work Location: In perso