Sr. Manager, Quality Engineering

Job Summary

Responsible for compliance with the Terumo Aortic Quality Management System and the applicable regulatory agency requirements and international standards for Class III Medical Devices. Performs product failure analysis, root cause investigations, risk assessment activities and identifies corrective/preventive actions to mitigate or eliminate reoccurrence of product quality issues. Responsible for oversight/management of supplier quality, process quality, and new product development quality. 

Job Details/Responsibilities

• Oversight/management of supplier quality, process quality, and new product development quality.
• Drive quality process improvements within manufacturing.
• Evaluate and improve current inspection processes, including implementation of SPC for inspection process monitoring.
• Interfaces with Research and Development and other engineering departments to determine whether the process and/or product changes are needed based on failure investigations.
• Must be able to perform training related to quality control standards, operating procedures, inspection, and test procedures.
• Assure all responsibilities are carried out in compliance with quality systems (i.e.ISO13485, 21CFR820), as well as all federal, state, and local government regulations.
• Updates Quality Assurance procedures as necessary to comply with Quality System requirements (i.e. ISO13485, 21CFR820).
• Ensures Quality metrics related to supplier quality, process quality, and new product development quality are reported monthly with strategies to address any metrics not meeting the goals.
• Ensures adequate investigation (with other departments if necessary) and adequate documented evidence of the root cause investigation(s).
• Ensures the proper documentation and implementation of any necessary corrective/preventive actions because of the complaint(s).
• Perform trending and statistical analysis for failures reported for the different product families.
• Ensures FMEA changes are completed as needed, based on risk assessments. 

Working Conditions/Physical Requirements

QUALITY REQUIREMENTS   

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who may be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Excellent Written and Verbal Communication 
• Ability to interact with all levels within the organization. 
• Excellent analytical skills and ability to analyze trending data into recommendations for improvements or preventive actions. 
• Mechanically inclined 
• Computer and software skills including all Microsoft Office applications, particularly Microsoft Excel. 
• Ability to motivate others and improve efficiency. 
• Understanding of quality system regulations (ISO 13485, 21 CFR 820, EU MDR 2017/745, Japanese MHLW) and any other international regulations, as applicable. 
• Sit/Stand/Walk 8 hours per day. 
• Light lifting 
• Demonstrate leadership; attention to detail and ability to solve problems and communicate issues. 

Qualifications/ Background Experiences

Minimum Knowledge & Experience required for the position: 

• BS in Engineering or Related Field 
• 7+ Years of Medical Device Manufacturing or related experience in a Regulated Industry 
• Understanding of quality system regulations (ISO13485, 21CFR820) 
• Knowledge of SPC, and statistical techniques used for trending and reporting.
• Prior experience in a lead Complaint role (administration function) of a Medical Device Manufacturing preferred 
• Knowledge of FDA & ISO requirements about Complaint processes and administrative functions is strongly preferred (For Complaint role)