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Biologics Principal Supplier Quality Engineer - San Diego, CA

San Diego, CA, United States

Join our dynamic Global Supply Chain Quality team at Hologic, where we oversee Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) suppliers. As a Supplier Quality Engineer (SQE) within Hologic’s Diagnostics Division, you will ensure our suppliers meet all regulatory and quality requirements. You'll foster positive relationships with CMs and OEMs, driving improvement projects across multi-functional areas to maintain compliance with applicable regulations and standards.

Responsibilities

+ Adhere to and support company policies and QSR/ISO Quality System requirements.

+ Serve as the face of Hologic Quality for CMs and OEMs suppliers.

+ Ensure compliance with regulatory standards and quality system requirements through periodic audits.

+ Monitor supplier activities, corrective/preventive actions, NCEs, metrics, and maintain supplier files.

+ Lead, coordinate, and balance workloads to meet organizational goals.

+ Support budget forecasts and ensure adherence to the approved budget.

+ Assist with the Supplier Audit program as needed.

+ Manage and address supplier change notifications and requests.

+ Implement global standard/harmonized Supplier Quality Assurance processes, including supplier qualification, certification, assessment, monitoring, PPAP, performance management, and quality issue resolution.

+ Participate in the Material Review Board and manage nonconforming products and components.

+ Resolve quality issues with CMs and OEMs, driving appropriate corrective/preventive actions.

+ Monitor quality metrics and key process indicators, identifying improvement opportunities and partnering with stakeholders to drive actions.

+ Apply corrective actions to address unacceptable trends and meet strategic objectives.

+ Support the implementation of design changes affecting CM/OEM products and processes.

+ Review and approve Contract Manufacturer process validation test plans, protocols, and reports to ensure compliance with medical device standards.

+ Validate test methods for verification and validation at supplier sites.

+ Execute Part/Process Qualification with CMs and/or OEMs.

+ Drive Continuous Improvement activities for Supplier Development, supporting cost savings and Quality performance enhancement.

+ Coordinate the initiation, review, and approval of product qualification plans with relevant SMEs and stakeholders.

+ Maintain up-to-date supplier quality records.

Experience

+ 8-10 years of engineering experience with knowledge of FDA Quality System Regulation, ISO 13485, and Medical Device Regulation.

+ 5+ years of experience in IVD/IVDR or medical device manufacturing or a related industry.

+ Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001.

Specialized Knowledge

+ ISO 13485 lead auditor certification.

+ In-depth understanding of Medical Device Regulations, IVDR, CFR 820, ISO-13485, ISO-14971.

+ Expertise in risk management (FMEAs), validations, and root cause analysis.

+ Proficiency in statistical methods and APQP, PPAP methodologies.

+ Strong knowledge of supplier quality management, production, and process controls in a regulated industry.

+ Experience in sterilization, injection molding, hardware manufacturing, and automation.

+ Skills in Statistical Process Control, Measure System Analysis, Supplier Qualification (IQ, OQ, PQ), Root Cause Analysis (Fishbone, 8D, 5Whys, & CAPA).

+ Project Management proficiency.

Education

+ BS or BA degree, preferably in BioMedical Engineering, Chemical Engineering, Industrial Engineering, or Quality Engineering.

+ ASQ Supplier Quality Engineer Certificate and Master's degree are a plus.

Why Join Hologic?

At Hologic, we are dedicated to fostering an environment where top talent can thrive. We provide comprehensive training upon joining and ongoing development opportunities throughout your career. We offer a competitive salary and annual bonus scheme, which will be discussed in detail by one of our talent partners. If you possess the right skills and experience, we encourage you to apply today. We look forward to hearing from you!

The annualized base salary range for this role is $114,800 - 179,500 and is bonus eligible. Final compensation will depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Agency and Third-Party Recruiter Notice:

Agencies must have a current, executed Hologic Agency Agreement to submit resumes. Agencies may only submit candidates to positions for which they have been invited 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.

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