Principal Supplier Quality Engineer

Hologic, Inc.; Marlborough (MA); On-site; USD 114,000 - 180,000; Full time

Job summary

Join a forward-thinking company as a Principal Supplier Quality Engineer, where you will drive supplier excellence and uphold the highest standards in quality. In this pivotal role, you will oversee supplier manufacturing processes, ensuring compliance with regulations and quality management systems. Collaborate with global teams to resolve quality issues and support audits, all while making a significant impact in a dynamic environment focused on innovation. If you are passionate about quality and eager to contribute to a global organization, this opportunity is perfect for you.

Qualifications

• 8-10 years in Supplier Quality/Quality Engineering roles.
• 5+ years in the medical device manufacturing industry.

Responsibilities

• Oversee supplier manufacturing processes and ensure compliance.
• Conduct technical reviews and manage non-conformities.

Skills

Supplier Quality Management

Communication Skills

Analytical Abilities

Organizational Skills

Data Analysis

Education

ISO 13485 Lead Auditor Certification

Bachelor's Degree in Engineering

Tools

ERP Systems

Microsoft Office Suite

Statistical Tools (SPC, TQM)

Job description

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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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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