Quality Assurance Engineer - 12 month FTC Cambridge, Cambridgeshire, United Kingdom As a leading innovator of women's health, we at Hologic are empowering people to live healthier lives everywhere, every day. Our quality and regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence with strategic and operational plans. As our Quality Assurance Engineer, you will provide support to acquired company sites, for on-market medical devices remediation and support. Facilitating reviews of QMS systems with a risk-based approach, and preparing for harmonization, your expertise will enable you to offer support and guidance to action items within the Integrated Quality Plan. What To Expect - Performs activities related to the IQP to support the integration of an acquired company. - Work closely with R&D to review design control procedures (output verification and validation) and if required update design documentation as required. - Assess change requests of product for impact to design, determine supporting information required for implementation of changes. - Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility and conformance to product requirements. - Reviews risk documentation for adequacy and updates risk files into the Hologic templates. - Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal procedures/policies. - Ensures the accuracy of data collected and thorough investigation of complaints. - Review reportability decisions and assist in reporting of MDRs; including a retrospective review of complaints and previous reportability decisions. - Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities. - Work closely with R&D, Manufacturing, Service, and Supplier Quality to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate. - Present trends from investigation findings and recommendations for improvement to management. - Implement Hologic procedures/processes, tools. - Assist with quick and effective resolution to quality issues, including ship hold and field actions. - Assist with managing field actions, including regulatory and field communication, and execution of deliverables. What We Expect - Expertise: Bachelor's Degree, preferably in an engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering - Knowledge - MDSAP, EU Medical Device Regulation, US/EU Medical Device Reporting and Vigilance - Collaboration: Works well with team members and internal teams such as marketing, product development, and customer support, pan-European - Skill : Strong analytical skills including trend and statistical analysis, interpersonal, and management skills. - Autonomy: Demonstrates independent decision making and prioritization, including independent resolution of conflicts. - Adaptability: Flexibility to adapt to changing market conditions, customer requirements, and company priorities. - Experience : a significant and demonstrable track record of managing projects in a medical device, pharmaceutical or heavily regulated industry - Proactive: Ability to anticipate challenges and take initiative to address them. - Resilience: Maintains a positive attitude and strong work ethic even in challenging situations. - Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviors. Why 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. Our talent partners can discuss our salary offering and any relevant bonus schemes with you. This is a 12M Fixed Term Contract Position We look forward to hearing from you LI-HE1