Descripción del Trabajo
Responsible for establishing and improving Quality Assurance practices and procedures.
Responsible for design and evaluation of Quality Systems sampling plans and inspection methods.
Responsible for reviewing and recommending solutions to quality problems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Know & follow EES policies and procedures and assure that direct reports know & follow EES policies & procedures related to work activities performed in area of responsibility.
• Evaluate and/or design sampling plans and process control plans for lot acceptance and control processes.
• Study the effectiveness of inspection activities.
• Design means for measuring accuracy and documenting of inspection work.
• Evaluate and recommend inspection gauges and test equipment.
• Investigate causes of sporadic defects.
• Provide consultation services to Quality Systems and Manufacturing departments.
• Hire, supervise and train QS technicians, as applicable.
• Implement process control systems.
• Provide technical support for component, product and process validations.
• Provide technical support for new product transfer.
• Coordinate training of manufacturing associates as applicable.
• Establish and maintain appropriate documentation as required for Quality Systems activities.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• Investigate identified quality problems.
• Develop systems for new processes as required.
• Coordinate Customer Complaint investigations on items returned to the Albuquerque facility for analysis.
• Support CAPA investigations and tasks, to determine root cause and corrective actions needed.
• Maintain trend information on field failures.
• Support manufacturing in analyzing manufacturing product lines to determine how or where, within the manufacturing or inspection process, the root cause of non-conformances or customer complaints exist.
• Execute Statistical Analysis that include: ANOVA, DOE, Weibull, GR&R, Capability, FMEA, KTA and SPC as required.
• Perform, enhance and validations: for manufacturing processes, gauges, equipment, software and computerized systems as required.
• Prepare written protocols as necessary.
• Provide leadership and initiative to QS organization through continuous improvement projects.
• Interface with manufacturing area and other support groups to ensure department objectives are met.
• Follow all company safety policies and other safety precautions within the work area.
• Promote safety to all associates that enter the work area.
• Attend required safety training.
• Ensure that direct reports employ safe practices.
• Environmental – Participate in EMS management structure toward implementation and maintenance of EMS including continual improvement; pollution prevention; objectives and targets; and regulatory compliance. Participate and support the ISO 14001 Certification and Regulatory Audit process. Implement and follow all applicable EMS procedures. Adhere to the site’s EHS Code of Conduct.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Report to Quality Operations Business Unit Manager.
• Excellent written and oral skills and the ability to organize and follow up on multiple priorities.
• Able to make solid decisions that will effectively support the business and company policies.
• Able to work in a self-paced environment and provide leadership to team as appropriate.
• Team player.
• Project Management.
• Able to understand application of regulatory requirements to the business.
• Able to analyze and develop quality methods. Responsible for writing clear and concise protocols, study reports, and procedures.
• This position requires consistent involvement with and knowledge of changes in regulations and standards.
• Aptitude to respond to shifting priorities through appropriate realignment of required tasks. Personal computers Proficiency required.
• Skilled in use of PC based systems including, but not limited to: word processing, inventory management, quality system, non-conforming product systems and data base management.
EDUCATION & EXPERIENCE REQUIREMENTS
• Bachelor’s Degree in Engineering or applied science.
• Minimum of three years’ experience in quality control in the medical product industry preferred