Service Quality Engineer Lead

About the role

Hologic is seeking a Service Quality Engineer Lead to join our Global Services organization. This role involves planning, directing, and coordinating programs to ensure compliance with quality processes and procedures. The ideal candidate will leverage their extensive experience to resolve complex issues creatively and effectively, driving continuous improvement.

Responsibilities

• Works on diverse and complex issues requiring in-depth analysis of variable factors
• Determines methods and procedures on new assignments and coordinates activities of other personnel
• Evaluates and helps to drive updates to Standard Work, including service processes, procedures, and systems
• Collaborates to increase the efficiency of service
• Develops 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
• Led 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 enhance installation first pass yield and reduce out of box failures
• Makes 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
• Prioritizes and manages multiple projects within design specifications and budget restrictions
• May lead division-wide quality initiatives
• Verifies that process and system improvements have increased efficiency and driven down costs
• Monitors and oversees services implementation and adherence to our quality systems
• Other duties as assigned by manager

Qualifications

• Bachelor’s degree (B.S.) in engineering (electrical, mechanical, software, or computer) required. M.S. preferred, with 8-12 years related industry experience
• Quality Engineer certification preferred
• Commitment to excellence and high standards, with strong organizational and analytical skills
• Strong understanding of core process methodologies and problem-solving techniques related to primary role
• Ability to generate and explain detailed proposals, guidelines, and procedures for the Quality Engineering functions to departmental and/or non-departmental personnel
• 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
• Certain 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
• Absolutely must be able to analyze and resolve non-routine product issues related to installation and service using independent judgment and inspection
• 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
• Absolutely must be able to analyze and resolve non-routine product issues related to installation and service using independent judgment and inspection
• Must possess the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization
• ASQ &/or RAPS Certifications are a plus
• Lead Auditor Certification is a plus
• Leverage Lean Six Sigma green or black belt certification is a plus

Benefits

The annualized base salary range for this role is $120,100 to $188,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.