Hologic, Inc. · 8 hours ago
Quality Engineer, Design Control
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is dedicated to advancing women's health and is seeking a Quality Engineer for their Design Quality team in San Diego. The role involves supporting quality activities related to Design Control efforts, ensuring compliance with FDA and ISO regulations, and collaborating with product development teams throughout the product lifecycle.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Work with product development teams to ensure appropriate design control measures are applied during the development and transfer of Hologic products
Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization and post launch surveillance and change management activities
Support research and development teams with platform or systems reliability testing and characterization with both hardware and software
Serve as core team member on New Product Development projects to ensure compliance with design controls, as well as identify and address potential product issues in the design
Assess design changes from a systems perspective, identifying risks, delivering design mitigations, and evaluating the effectiveness of the risk control measures
Support design control and risk management activities, review/approve design control and risk management documentation ensuring compliance to established requirements
Provide guidance to core team members and key stakeholders on Quality Systems requirements and Design Controls
Participate in project teams to review and update clear and concise user requirements, product specs, plans, verification and validations studies, risk management file and other relevant design control deliverables
Support FMEAs and other risk assessment processes and documentation
Lead or support non-conformance or CAPA related initiatives with NCE and CAPA process
Support regulatory inspections and audits associated with design control documentation
Qualification
Required
Bachelor's degree in engineering or a life science discipline or equivalent
Minimum of 2 – 5 years of experience, specific to design control/quality product design experience in a regulated environment, ideally in the IVD space
Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards
Extensive experience and understanding of design, development, verification, and validation processes
Strong knowledge of scientific principles and concepts
Experience with design, developing, and implementing Design Control Quality Systems SOPs, forms, protocols, report templates
Advanced working knowledge of, and experience with design control, design change management, quality control and documentation requirements
Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP) and quality system tools (e.g. electronic CAPA, complaint management systems)
You are a good communicator, a team player, an 'out of the box' thinker
You have strong influencing and negotiation skills
Benefits
PTO
Employee Stock Purchase Plans
Exciting Employee Wellness plans
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
Company data provided by crunchbase