Principal Plastic Supplier Quality Engineer - Londonderry, NH

Position Overview: This role supports the Global Supplier Quality organization, focusing on the oversight and quality assurance of components, subassemblies, and services. The position requires technical expertise to ensure suppliers meet all necessary requirements.

Key Responsibilities:

• Ensure compliance with regulatory standards and Quality Management System requirements related to supplier quality management.
• Conduct thorough technical reviews to assess supplier capabilities for material production.
• Oversee and monitor supplier processes, including manufacturing, quality control, corrective actions, continuous improvement, and First Article Inspection.
• Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts, ensuring timely completion.
• Collaborate with suppliers to exceed fit, form, function, and reliability requirements, while working with internal teams such as Research & Development and Design Assurance.
• Issue and track Agile Quality figures (SCARs, SACAs, NCEs) related to supplier components, ensuring compliance with key performance indicators.
• Work with suppliers on problem-solving and root cause analysis to prevent recurring issues, applying metrology and statistical measurement where applicable.
• Coordinate with Post Market Surveillance and other departments to address complaints linked to supplier issues.
• Resolve daily quality issues with global suppliers by addressing non-conformities and coordinating with relevant departments for raw material disposition.
• Manage the inclusion and removal of suppliers from the Skip Lot Program as needed.
• Maintain comprehensive supplier quality records and update supplier files to ensure accuracy and regulatory compliance.
• Support audits as a subject matter expert and travel as required.
• Update the ERP system with the status of approved suppliers for various materials.
• Attend and follow up on action items from functional and departmental meetings.
• Coordinate and execute changes in specifications or procedures through the appropriate change order process.
• Complete necessary training in respective procedures before task execution.
• Generate supplier performance metrics and provide reports to stakeholders.
• Coordinate Periodic Quality Review meetings with suppliers and ensure follow-through on agreed activities.
• Manage the implementation of new suppliers due to new product introductions, product transfers, or alternate supplier sourcing, ensuring compliance with quality system requirements.
• Qualify new suppliers or new parts/components from approved suppliers.
• Perform additional duties as assigned by supervisor/manager.

Qualifications:

Education:

• Bachelor's degree in Materials, Plastic, Injection Modeling, Electrical Engineering, or a related field preferred.
• ASQ Supplier Quality Engineer Certificate (desirable).

Experience:

• 8-10+ years in Supplier Quality/Quality Engineering.
• 5+ years in medical device manufacturing or a related industry.
• Technical expertise in Electronics/Plastic/Metals processes, such as printed circuit board assemblies, cables, machined parts, etc.
• Valid driver's license.

Skills:

• Effective communication skills (written and verbal) at all organizational levels.
• Knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 (required).
• Project management skills.
• Proficiency in problem-solving tools (SPC, TQM, etc.) for process optimization.
• Analytical skills to evaluate data and translate it into actionable plans.
• Ability to work independently and collaboratively within the organization.
• Proficient in Microsoft Office suite for report generation and data analysis.
• ISO 13485 lead auditor (required).
• Risk management, validations, and root cause analysis experience (required).
• PPAP knowledge (desirable).
• Familiarity with Agile and Oracle (desirable).

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 and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $114,800-179,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.