Sr. Manager Supplier Quality Engineering - San Diego, CA - San Diego California

Company: Hologic, Inc.
Location: San Diego, California
Posted On: 01/30/2025

The Supplier Quality Manager ensures suppliers continuously improve by adopting best practices for defect prevention, reducing variation and waste, and fostering continuous improvement to meet quality standards. The role involves managing a team of Supplier Quality Engineers and ensuring adherence to procedures.Essential Duties and Responsibilities:

• Lead and develop a team of Supplier Quality Engineers.
• Implement standardized Supplier Quality Assurance processes.
• Educate suppliers about company requirements and expectations.
• Monitor and report key supplier quality metrics.
• Support supplier selection and approval.
• Collaborate with underperforming suppliers to resolve quality issues.
• Identify and address systemic supplier quality issues using LEAN and continuous improvement tools.
• Prioritize suppliers for management using a risk-based approach.
• Partner with Supply Chain to address delivery issues and claims recovery.
• Facilitate networking and recognize high-performing suppliers.
• Implement and monitor Quality Agreements with suppliers.
• Contribute to the Supplier Quality Auditing risk management process.Physical Demands:
  • Sit, use hands, stand, walk, reach, stoop, kneel, crouch, or crawl.
  • Domestic and international travel required.Qualifications:Education:
    • BS with 12 years, MS with 10 years, or PhD with 8-10 years of related experience in a scientific discipline or engineering.Specialized Knowledge:
      • Required: IVDR, Medical device regulations (21CFR), ISO 13485, ISO 9001, Medical Device Single Audit Program, and other international regulations.
      • Knowledge of the automotive APQP process is a plus.Experience:
        • Experience in in-vitro diagnostic, medical device, biotech, or pharmaceutical industry.
        • At least 5 years of supervisory experience.Skills:
          • Proficient in various validation methods and evaluation criteria.
          • Advanced knowledge of process transfer, materials control, change control, manufacturing processes, and product testing.
          • Familiarity with engineering drawings, FDA interactions, and risk management documentation.
          • Expertise in generating validation plans and reports.
          • Team leadership and development experience.
          • Proficient in process validation, analytical methods, cleaning validation, and equipment qualifications.
          • Knowledge of electronic document management systems, statistics, SPC, and acceptance sampling.
          • In-depth knowledge of QSR, CDRH, CBER, ISO regulations, IVDR, and familiarity with MDR.
          • Excellent communication skills.
          • Strong computer skills and ability to multi-task.
          • Fluent in English; a second language is a plus.
          • Intermediate to advanced proficiency in Microsoft Office.So why join Hologic?We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.Role is located in San Diego, CAThe annualized base salary range for this role is 145,500-242,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
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