Sr. Supplier Quality Engineer

Hologic; Newark (DE); On-site; USD 94,000 - 147,000; Full time

Job summary

A leading company in the medical device sector is seeking a Sr. Supplier Quality Engineer to oversee quality processes and ensure compliance with regulatory standards. This role involves collaboration with teams and suppliers to improve quality and support product introduction, offering an opportunity for impactful contributions.

Qualifications

• 5+ years in medical device manufacturing or related industry.
• 2–3+ years in Quality Assurance is desirable.
• Experience with supplier onboarding, audits, and quality metrics.

Responsibilities

• Oversee supplier quality processes and compliance with standards.
• Collaborate with teams and suppliers to solve quality issues.
• Support the introduction of new products and suppliers.

Skills

Communication

Project Management

Negotiation

Attention to Detail

Agile Methodology

Analytical Skills

Job description

We are seeking a skilled and detail-oriented Sr. Supplier Quality Engineer to join our team. In this role, you will oversee supplier quality processes, ensure compliance with regulatory standards, and maintain the highest levels of quality for materials and components sourced globally. You will collaborate with internal teams and external suppliers to drive continuous improvement, resolve quality issues, and support the introduction of new products and suppliers.

This position offers a dynamic opportunity to contribute to the development and maintenance of a robust supply chain for high-quality products, with a focus on meeting regulatory requirements and exceeding customer expectations.

Knowledge:

• Comprehensive understanding of supplier quality management processes and regulatory compliance standards (21 CFR, ISO 13485, ISO 9001).
• Expertise in quality tools such as PPAP, SPC, root cause analysis, and risk management.
• Familiarity with medical device regulations and industry standards like cGMP, CFR 820, and ISO 14971.
• Specialized knowledge in validating new suppliers, components, and processes, as well as maintaining supplier quality records and certifications.
• Knowledge of automotive APQP processes is a plus.

Skills:

• Strong communication skills (both written and verbal) to effectively collaborate with internal teams and external suppliers.
• Proficiency in Microsoft Office Suite for data analysis, reporting, and presentations.
• Ability to manage multiple complex projects with strong organizational and project management skills.
• Negotiation skills to effectively resolve supplier quality issues and drive improvement initiatives.
• Desirable skills include familiarity with Agile and Oracle systems, ISO 13485 Lead Auditor certification, and Quality System Regulations.

Behaviors:

• Detail-oriented and methodical in managing supplier quality processes and records.
• Proactive and solutions-focused, with a commitment to continuous improvement and regulatory compliance.
• Collaborative and team-oriented, working effectively with global suppliers and cross-functional teams.
• Resilient and adaptable, capable of managing competing priorities in a fast-paced environment.
• Ethical and customer-focused, ensuring supplier quality aligns with product reliability and customer expectations.

Experience:

• 5+ years of experience in medical device manufacturing or a related industry.
• 2–3+ years of experience in a Quality Assurance function (desirable).
• Proven track record of managing supplier quality processes, conducting technical reviews, and resolving quality issues.
• Experience coordinating supplier onboarding, qualification, and Production Part Approval Process (PPAP) activities.
• Hands-on experience with audits, supplier performance metrics, and addressing post-market complaints related to supplier performance.

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 $94,000- $146,900 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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