Senior Quality Engineer

Your challenge

•    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

Authority:
•    Review and approve investigation
•    Review and approve calibration documents
•    Review and approve validation documentations 
 

Your Profile

Job Requirements:
•    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 ISO13485, ISO14971, 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/SolidWorks
•    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

Physical Requirements:
•    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