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Principal Supplier Quality Engineer

Marlborough, MA, United States

Are you passionate about driving supplier excellence and ensuring compliance in a fast-paced, global environment? We’re seeking a **Principal Supplier Quality Engineer** to join our **Global Supplier Quality Organization** and uphold the highest standards in components, materials, and services.

In this role, you’ll oversee supplier manufacturing processes, conduct technical reviews, and ensure adherence to regulatory standards and Quality Management System (QMS) requirements. You’ll define and approve **Production Part Approval Process (PPAP)** requirements, qualify new suppliers, monitor performance metrics, and drive continuous improvement. Collaborating with suppliers and internal teams, you’ll resolve quality issues, manage non-conformities, and support audits globally.

If you’re ready to make an impact in a global organization focused on quality and innovation, apply today!

Knowledge

+ Strong understanding of **Medical Device Regulations** (e.g., ISO-13485, ISO-14971, ISO-9001, CFR 820, FDA requirements).

+ Expertise in supplier quality management processes, manufacturing practices, and engineering principles.

+ Knowledge of **Production Part Approval Process (PPAP)** and **Quality Management Systems (QMS).**

+ Familiarity with statistical tools (e.g., SPC, TQM), risk management practices, and root cause analysis methodologies.

+ Proficiency in ERP systems and Microsoft Office Suite (Intermediate to Advanced).

Skills

+ Exceptional written and verbal communication skills for effective collaboration with suppliers and internal stakeholders.

+ Advanced analytical abilities to identify, evaluate, and resolve quality issues.

+ Strong organizational skills to manage multiple complex projects simultaneously.

+ Ability to generate, analyze, and present supplier performance data to support decision-making.

+ High level of precision in managing supplier records and monitoring compliance.

Behaviors

+ Takes initiative to identify and address supplier quality issues before they escalate.

+ Builds strong relationships with internal teams and external suppliers to achieve shared goals.

+ Ensures accuracy and thoroughness in all aspects of supplier quality management.

+ Thrives in a fast-paced, global environment with shifting priorities.

+ Focuses on delivering measurable improvements in supplier performance and compliance.

Experience

+ 8-10+ years in Supplier Quality/Quality Engineering roles.

+ 5+ years in the medical device manufacturing or related industry.

+ ISO 13485 Lead Auditor Certification.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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.

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, 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._

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