Quality Engineer, Design Control

Hologic•San Diego, CA

11d•Onsite

About The Position

Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women’s health. We achieve this by fulfilling our promise to bring The Science of Sure to life. We are hiring for a Quality Engineer in our Design Quality team, onsite here in San Diego! As a key member of the Quality Engineering team, you will play an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company’s quality system activities and design comply with the FDA’s Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. Key Outcomes 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. Do you have what it takes? You are a good communicator, a team player, an "out of the box" thinker. You have strong influencing and negotiation skills. 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)

Requirements

You are a good communicator, a team player, an "out of the box" thinker.
You have strong influencing and negotiation skills.
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)
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.

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.