Quality Supervisor 2nd Shift

Job Summary

Provide leadership to the Quality Operations team to deliver the required business support which includes quality inspections & testing, nonconformance handling on a day-to-day basis. This position requires excellent people skills and knowledge in quality systems, and manufacturing processes.  This position also has the purpose to ensure compliance to company/divisional policies, procedures and with FDA and ISO requirements by reviewing non-conformances, complaints, defect reports, and audit findings in order to coordinate corrective action. Will have responsibility for quality compliance for all products produced in the Terumo, Puerto Rico LLC (TPR) facility.

Job Details/Responsibilities

Supervisory Responsibilities

• Provide leadership and guidance to a team of associates, including assigning tasks, setting clear goals, and monitoring performance.
• Provide leadership to Quality Inspectors and/or technicians to perform the required Quality tasks and coordinate schedules, staffing and deliverables to comply with company goals.  
• Provide training to Quality Inspectors in product inspection & testing, nonconformance handling, quality task as required to ensure team members are equipped with necessary skills and knowledge.  
• Develop individual team members through coaching and mentoring.
• Conduct regular performance evaluations, provide constructive feedback, and implement performance improvement plans as needed.  Recognize and reward outstanding performance.
• Ensure smooth operations by coordinating workflows, resolving issues, and addressing concerns promptly. 

Quality Operations

• Maintain high standards of quality, productivity, and efficiency.  
• Prepare reports to communicate QC’s production progress, accomplishments, and issues on a frequent basis.  This may include leading and having daily meetings with staff and peers to discuss issues. 
• Evaluates and validates daily QC’s production metrics and establishes mechanisms to ensure that all processes are in compliance with standard procedures.
• Assures product dispositions are being completed in a timely manner. 
• Assures that DHR reviews and release dispositions are conducted in a timely manner. 
• Responsible for the segregation of nonconforming materials and initiation of NCR form to present to board.
• Reconciliation and final disposition of nonconforming material.
• Responsible to elevate issues of quality immediately and be closely involved in the investigation and solution of quality issues.
• Support manufacturing related complaints that include conducting DHR’s review, trending, monitoring, and record keeping.  
• Implement systems to track and follow-up data sources metrics.  
• Responsible to update the quality metrics by following up and gathering all the require quality information. 

Job Responsibilities (continued)

• Prepare management review data including trends, paretos, gap analysis, among others.  
• Work on continuous improvement initiatives to improve our quality system.   Must be fully conscious of the QS Regulation and ISO Standards. 
• Provide regulatory training to the facility teams if required.
• Create protocols and reports for testing equipment and Test Method Validations.
• Perform or assist in the investigation of information during regulatory inspections and field actions.
• Participate in regulatory agencies audits (internal and external).
• Perform manufacturing non conformances investigations reports, customer complaints, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action.  
• Ensure compliance with all TPR procedures and all applicable regulatory agency requirements. 
• Contribute to a positive work environment by fostering open communication with team members, other departments, and management, promote teamwork, and commitment to excellence.  
• Other duties as assigned.
   

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Should have full knowledge and understanding of the standards applicable to the facility (e.g.  FDA QS regulation, CFR 820, Medical Device Directive, Canadian Device Regulation, and ISO 13485.   
• Must have excellent audit and reporting writing skills including ability to write technical reports. 
• Must have good verbal and written communication in English and Spanish Computer knowledge program as Excel, Power Point and Word is a must. 
• Willing to travel.  
• Must have supervisory experience with teams of indirect personnel.
• Training in Basic statistics, Quality Auditing, Computer, QSR and ISO13485:2003 and Failure Investigation.  
• Quality systems auditing experience. 
• Ability to work under deadlines.  
• Should have fundamental knowledge/experience in statistics, SPC, Validation activities: Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification
   

Qualifications/ Background Experiences

• Bachelor’s degree in any field; Science of Engineering, Sciences or Administration is preferred.
• A minimum of (5) five years work-related experience in FDA regulated environment, such as Medical Devices or Pharmaceutical. 
• At least 3 years of previous experience in a medical device, biotechnology, pharmaceutical industry, or related experience.