Hologic Supplier Quality Engineer Scientist in San Diego, California

Supplier Quality Engineer Scientist

Post Date May 23, 2018

Job Summary

The Operations Scientist 3 supports various areas of manufacturing including production and testing with an emphasis on raw materials using technical knowledge for resolution of issues or improvements related to product or processes .

Duties & Responsibilities:

  • Collaborates with external suppliers and business partners to support raw material business continuity, improvements, change notifications, quality issues, and continuity of supply

  • Prepares and executes protocols and reports. Generates data summaries with complex statistical analysis.

  • Leads complex studies with strategic impact.

  • Generates statistically based test plans.

  • Collaborates with internal customers to develop or modify policies and procedures.

  • Generates clear and concise investigations and reports

  • Defines and implements VIP pipeline to achieve 5% cost reduction goal.

  • Leads enhancement/ obsolescence projects.

  • Evaluates and submits proposals for specification changes.

  • Executes tasks with a good understanding of root cause analysis and scientific method.

  • Supports the development or modification of raw material specifications.

  • Supports regulatory affairs with technical submissions.

  • Provides SME support in internal and external supplier audits.

  • Performs Design/Risk assessments for change orders.

  • Participates in the development of pFMEAs.

  • Reviews and provides feedback and assistance to others on writing technical reports.

  • Participates in formal presentation of technical information (may be product or process).

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.

  • Ability to work independently with little to no supervision on increasingly complex projects.

  • Demonstrates ability to follow standard protocols and exhibit strong laboratory skills within a GMP/GLP laboratory setting.

  • Demonstrates strong peer to peer communication skills.

  • Adherence to FDA cGMP, ISO13485, company and department procedures.

  • Good understanding of design control and risk management including pFMEA development.

  • Ability to make sound decisions within approval limits.

  • Ability to clearly summarize and present technical and complex information to a broad range audience both verbally and written.

  • Able to resolve technical problems using systematic reasoning and root cause tools.

  • Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.

  • Demonstrates knowledge of and has the ability to apply stability regulations, statistical process control, AQL, and sound statistical reasoning.

  • Extensive experience with Microsoft Office (Words, Excel, PowerPoint).

  • Working knowledge of LIS/Instrument files and relationship to LIMS/NWA processes preferred.

  • Working knowledge of LEAN concepts such value stream mapping, 6-Sigma and Kaizen events preferred.

  • Working knowledge and experience with REACH, RoHS and conflict minerals highly preferred

  • Experience with electronic product life cycle systems such as Agile and Oracle highly preferred.

Education:

BS and 6 years or MS and 4 years or PhD and 0-2 years related experience in scientific

Experience:

Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.

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.