Service Quality Engineer Lead

Hologic, Inc. is a leader in women's health innovation, empowering people to live healthier lives. They are seeking a Service Quality Engineer Lead to oversee compliance with quality processes and enhance service quality through data analysis and process improvement.

Responsibilities:

• Works on diverse to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
• Determines methods and procedures on new assignments and may coordinate activities of other personnel
• Evaluates and helps to drive the update to Standard Work, including all service processes, procedures, and systems to improve reliability and repeatability while maintaining compliance to regulatory requirements
• Collaborates to increase the efficiency of service
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of services and their delivery
• Investigates and thoroughly understands developments in quality compliance and standards
• Optimizes Service’s installation processes to efficiently detect defects in early project stages
• Performs defect analysis utilizing experience in statistical quality process analytical methods
• Leads the detection and prevention of non-conformances to improve business results in terms of service costs, customer uptime, service vendor and process compliance
• Partners with Operations to aid in enhancing installation first pass yield and reduce out of box failures
• Monitors and analyzes service performance trends for key quality metrics and establishes appropriate control measures
• Coordinates with Operations, R&D, and Regulatory to conduct risk analysis of non-conformances found at installation and drives collaboration and communication for issue resolution through CAPAs, non-conforming material risk analysis, design verification and validations
• Reviews returned material from installation and verifies non-conformances through root cause analysis; develops and executes action plan to address discrepancies; communicates with the manufacturer as required
• Facilitates resolution of MRB issues leading to reduction in number of parts and components used in the provision of service
• Performs statistical analysis to assess the cost of, and determine the responsibility for parts and components that do not meet required standards and specifications
• Supports product field action initiatives
• Prepares and maintains a variety of reports; data trending; manages documentation control systems
• Leads external and internal quality audits
• Conducts quality audits and evaluations
• Communicates and resolves QC issues with Field Service on a day-to-day basis
• Participates in the selection of install/service vendors for the Division
• Coordinates improvement efforts with vendor discrepancies
• Prioritizes and manages multiple projects within design specifications and budget restrictions
• May lead division wide quality initiatives
• Using data, verify that process and system improvements have increased efficiency and driven down costs
• Has responsibility for the monitoring and oversight of services implementation and adherence to our quality systems
• Other duties as assigned by manager

Requirements:

• Bachelor's degree (B.S.) in engineering (electrical, mechanical, software, or computer) required
• M.S. preferred, with 8-12 years related industry experience
• Commitment to excellence and high standards, with strong organizational and analytical skills
• Possesses strong understanding of core process methodologies and problem-solving techniques related to primary role
• Possesses ability to generate and explain detailed proposals, guidelines, and procedures for the Quality Engineering functions to departmental and/or non-departmental personnel
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Proven ability to handle multiple projects and meet deadlines; Demonstrated ability to plan and organize projects
• Competent understanding of ISO 9001, ISO 13485, and GMP regulations
• Familiar with design control principles and basic inspection techniques
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization
• Must be able to analyze and resolve non-routine product issues related to installation and service using independent judgment and inspection
• Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization
• Quality Engineer certification preferred
• ASQ &/or RAPS Certifications are a plus
• Lead Auditor Certification is a plus
• Lean Six Sigma green or black belt certification is a plus