Senior Quality Engineer

Responsibilities

• Set detailed guidelines on inspection and testing requirements
• Ensure products adhere to company and industry quality standards
• Develop inspection methods to analyze product quality
• Identify and lead CAPA and process improvement initiatives
• Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations.
• Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
• Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
• Deploy variation management tools and techniques at select suppliers to mitigate risk
• Audit suppliers and establish supplier quality requirements
• Reporting on supplier trends for management review and notification of identified trends to management for management review
• Design and implements methods for process control, process improvement, testing, and inspection
• Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
• Other duties as assigned

• Set detailed guidelines on inspection and testing requirements
• Ensure products adhere to company and industry quality standards
• Develop inspection methods to analyze product quality
• Identify and lead CAPA and process improvement initiatives
• Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations.
• Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
• Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
• Deploy variation management tools and techniques at select suppliers to mitigate risk
• Audit suppliers and establish supplier quality requirements
• Reporting on supplier trends for management review and notification of identified trends to management for management review
• Design and implements methods for process control, process improvement, testing, and inspection
• Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
• Other duties as assigned

• Bachelor’s degree in engineering field or related field. Master’s degree in engineering is preferred.
• 3-7 years of experience in high volume regulated manufacturing industry in engineering field.
• Working experience of Six Sigma, lean and Quality Management Tools
• A broad knowledge of theory and principles of statistics and statistical process control
• Experience with Access Database, Excel and complaint handling software.
• In-depth knowledge of ISO
  13485, ISO
  14971, CFR part 820.
• Good understanding of medical device regulation, industry, and international standards.
• Strong computer skills in MS Office
• Ability to recognize and projects
• Ability to read and understand technical drawings and documents
• Working experience on CAD/Solid Works
• Ability to work independently and take initiative
• Excellent communication, analytical, trouble-shooting and interpersonal skills
• ASQ Lead Auditor or equivalent training in auditing
• A team player as well as the ability to work independently

• Must be able to work overtime as needed
• Must be able to sit, stand and walk for up to 8 hours
• Must be able to lift up to 70 lbs

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.