Supplier Quality Engineer 4 - Newark, DE Newark, DE, United States **Job Overview:** We are seeking an experienced Supplier Quality Engineer to join our Global Supplier Quality organization. This role will be instrumental in ensuring our suppliers meet all regulatory and quality management standards. The successful candidate will bring technical expertise to oversee components, subassemblies, and services, ensuring that our high standards for quality are met. **Key Responsibilities:** + Ensure supplier compliance with regulatory standards and Quality Management System requirements. + Conduct thorough technical reviews to assess supplier capabilities in producing materials. + Oversee, assess, and monitor suppliers' manufacturing processes and quality control practices. + Define and approve PPAP requirements for new and revised purchased parts. + Collaborate with suppliers to meet "fit, form, and function" and reliability requirements. + Issue and follow up on SCARs, SACAs, and NCEs related to supplier components. + Work with suppliers on problem-solving and root cause analysis to prevent recurrence of issues. + Address complaints linked to supplier quality in collaboration with relevant departments. + Resolve day-to-day quality issues with suppliers, including non-conformities. + Maintain comprehensive supplier quality records and update as needed. + Support audits as a subject matter expert, with potential travel required. + Update the ERP system with the status of approved suppliers. + Attend functional and departmental meetings, following up on action items. + Coordinate changes in specifications and procedures as needed. + Generate supplier performance metrics and provide reports to stakeholders. + Coordinate and execute activities related to the implementation of new suppliers. + Perform other duties as required by the supervisor/manager. **Required Qualifications and Skills:** + Bachelor’s degree in Materials, Electronic, Electric Engineering, or related field preferred. + 8-10 years of experience in Supplier Quality/Quality Engineering. + 5+ years of experience in medical device manufacturing or related industry. + Technical knowledge in Electronics/Plastic and/or Metals processes. + Full clean driver’s license. + Strong communication skills, both written and verbal. + Working knowledge of Medical Device Regulations, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001. + Proficiency with Microsoft Office suite. + ISO 13485 lead auditor, risk management, validations, and root cause analysis skills. **Preferred Qualifications:** + ASQ Supplier Quality Engineer Certificate. + Proficiency with Agile and Oracle. + Experience with PPAP processes. **Benefits and Perks:** + Competitive salary and benefits package. + Opportunities for professional growth and development. + Collaborative and supportive work environment. + Health, dental, and vision insurance. + 401(k) retirement plan with company match. + Paid time off and holidays. **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. We offer a competitive salary as well as quarterly commission based on sales target. If you have the right skills and experience and want to join our team, **apply today.** The total compensation range for this role is 114,000-179,500. This is based on a base salary and commission plan combination. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, territory/ geography, education, business needs, market demand and performance versus quota **Agency and Third Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. \#LI-LB2