Service Quality Engineer Lead

Hologic

10h

About The Position

At Hologic, a leader in women's health innovation, we empower people to live healthier lives every day. We are looking for a Service Quality Engineer Lead to join our Global Services organization. In this pivotal role, you will be responsible for planning, directing, and coordinating preparation and implementation programs to ensure compliance with the company’s quality processes and procedures. As a seasoned professional with deep expertise in your area of specialization, you will draw on your wide-ranging experience to resolve complex issues in creative and effective ways. You will also play a key role in driving continuous improvement by monitoring process data, analyzing trends, financial results, and customer feedback, and using those insights to increase efficiency and elevate service quality across the department and the broader organization.

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

Nice To Haves

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

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