Hologic Supervisor, Quality in San Diego, California

Supervisor, Quality

Post Date Apr 06, 2018

Hologic is seeking a Quality Supervisor (Non-Conformances) who will continue to maintain the turn-around-time and compliance expectations for non-conformances.

DESCRIPTION OF POSITION RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Supervises the team that reviews and assesses the appropriateness of non-conformances in accordance with internal procedures.

  • Leads the Material Review Board meetings and Product Quality Committee meetings, as needed.

  • Acts as the Quality team lead on the Product Response Team.

  • Assists in external audits & Regulatory Body audits.

  • Represents QA as a team member on cross-functional special project teams.

  • Conducts new employee training programs.

  • Develops and maintains department Standard Operating Procedures, as needed.

  • Performs queries to provide non-conformance trends for investigations.

  • Develops, maintains & reports department metrics, as needed.

  • Leads team process improvement activities.

KNOWLEDGE AND SKILLS:

  • Knowledge of FDA Quality System Regulations, ISO 13485 and Risk Management.

  • Advanced knowledge of Microsoft Word, Excel and related functions including the formulation of graphs.

  • Experience working in ERP systems is strongly preferred.

  • Outstanding oral and written skills including technical writing are required.

  • Must be a self-starter, able to multi-task and enjoy working in a highly detailed environment.

EDUCATION AND EXPERIENCE REQUIREMENTS:

  • Typically requires BA or BS and 5-8 years related experience

  • Previous supervisory experience.

  • 5+ years of Quality experience with a strong emphasis in Quality Systems and Non-Conformances.

  • Experience with Regulatory Inspections is preferred. 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 inclusive of disability and veterans.