Senior Quality Engineer

Aug 13, 2017
Aug 15, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Overview A Senior Quality Engineer would work on a range of products in Hologic's Breast and Skeletal Health Division on product systems that include digital imaging equipment. You will work in a multi-disciplinary group, contributing to the sustaining manufacturing of Hologic's innovative products focusing on the production and process controls including capital equipment with both electrical systems and software. Role Provide quality engineering support in the production of medical device products, and facilitate the application of production and process controls including continuous improvement. Provide quality engineering support to various manufacturing sites and contract manufacturers when process changes are required. Essential Duties & Responsibilities
  • Actively support production through the application of risk management, production and process controls (including process validation), test method validation and quality engineering tools.
  • Provide quality engineering expertise to maintain and improve product quality by investigating customer complaints, analyzing nonconforming material reports, partnering with Engineering, Operations and Service on design transfers and process validations and partnering with Supply Quality regarding supplier performance.
  • Participate as a member of the MRB and the dispositioning of nonconforming product and components.
  • Monitor quality metrics (e.g. field, manufacturing and inspection) and key process indicators to identify opportunities for improvement and partners with Operations, Service and Engineering to drive actions. Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives.
  • Lead and/or participate in multi-departmental and multi-site teams to implement product quality initiatives.
  • Support the implementation of design changes.
  • Lead and/or participate in manufacturing/supplier transfer activities (planning, qualification, etc.)
  • Review and approve process validation test plans, protocols and reports. Ensure validation results demonstrate compliance to medical device standards.
  • Review test methods for quality of verification and validation of the method.
  • Interact with Operations to ensure products are manufactured in accordance with QSR, cGMP and ISO 13485:2003.
  • Assist in the design and implementation of policies and procedures for verification and validation of processes and/or equipment.
  • Participate in product risk assessment efforts, including process failure mode effect analysis, within product teams and updates to existing product lines.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Skilled in requirements analysis, including testable and measurable specifications
  • Experience with test methods and standards for the validation of manufacturing and test methods for medical device products
  • Skilled in test plan development and root cause failure analysis
  • Skilled in quality engineering tools and disciplines such as process design, production and process controls, quantitative methods and tools, continuous improvement, etc. (e.g. Cost of Quality)
  • Good verbal (including presentation) and written communication skills, especially technical report writing
  • Ability to effectively work on project teams
  • Ability to appropriately assess written design, process and device documentation as the principle advocate for compliance
Preferred Skills/Qualifications
  • Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Familiar with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
  • Skilled in statistical methods and design of experiments
  • Experience utilizing standard root cause analysis tools (5-Why, FTA, fishbone diagrams, etc.)
  • Manufacturing engineering or manufacturing quality engineering experiences a plus
  • Certified Quality Engineer certification
  • BS in an engineering discipline
  • 8-10 years of engineering experience, preferably with capital equipment including process validation
  • Strong working knowledge of production and process controls in a regulated industry
  • Strong working knowledge of risk management for medical device products
  • Experience with test methods and standards for the validation of manufacturing of medical device products
  • Skilled in test plan development and root cause failure analysis
  • Working knowledge of supplier quality management
Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor MON