Principal Supplier Quality Engineer - Newark, DE

Hologic's Global Supplier Quality team seeks an experienced Supplier Quality Engineer (SQE) to oversee Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) Suppliers. The SQE ensures suppliers meet Hologic's standards, builds relationships, and drives improvement projects to comply with regulations and standards.

Key Responsibilities:

• Ensure compliance with regulatory standards and Quality Management System requirements.
• Resolve quality issues with CMs and OEMs, driving corrective/preventive actions.
• Implement global Supplier Quality processes and participate in supplier audits.
• Manage supplier change notifications and monitor quality metrics.
• Support design changes, participate in the Material Review Board, and conduct technical reviews.
• Define and approve PPAP requirements, collaborate with suppliers on product requirements, and issue Agile Quality figures.
• Perform root cause analysis, solve problems, and address supplier-related complaints.
• Maintain accurate supplier records, update ERP systems, and attend meetings.
• Coordinate new supplier implementation and part/process qualification.
• Support continuous improvement activities and create quality agreements.

Physical Demands:

• Sit, stand, walk, and use hands to handle objects.
• Exposure to moving mechanical parts, vibration, and moderate noise.
• Wear safety shoes in designated areas.
• Domestic and international travel required.

Qualifications:

• Bachelor’s degree in Electronics, Mechanical Engineering, or related field.
• ISO 13485 leader auditor certification required.
• Knowledge of medical device regulations, cGMP, CFR 820, MDR/IVDR, ISO-13485.
• Experience with risk management, validations, root cause analysis, and supplier quality management.
• Proficiency in statistical process control, measure system analysis, and supplier qualification.
• 10+ years in engineering within medical device manufacturing or related industry.
• 3-5+ years in supplier quality/quality engineering role.

Skills:

• Effective communication, both written and verbal.
• Ability to work independently and collaboratively.
• Proficiency in Microsoft Office suite.
• Proficiency in English; a second language is a plus.

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.

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