Senior Supplier Quality Engineer - Exton, PA

dsm-firmenich; Exton (PA); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Health benefits

Competitive compensation

Job summary

dsm-firmenich Exton, PA is seeking a Senior Supplier Quality Engineer to oversee supplier quality for biomedical products. You will lead supplier qualifications, audits, and data-driven improvements across multiple product lines, interfacing with R&D, production, and external vendors.

The role requires 8–12 years in quality engineering or supplier management in regulated settings, ISO13485 and 21 CFR820 familiarity, and strong analytical and leadership skills.

Qualifications

• 8-12 years of Quality Engineering or Supplier Management in regulated industries.
• Experience with FDA-regulated medical devices or similar sectors is required.
• Proven ability to lead supplier qualification and audits.

Responsibilities

• Serve as primary quality contact with vendors of all sizes and complexities.
• Own and manage the supplier qualification process and Approved Supplier List.
• Develop, document, and implement QA Procedures.
• Lead external audits of CMOs/suppliers and drive corrective actions.
• Analyze non-conforming materials and initiate disposition and corrective actions.

Skills

Supplier management

Data analysis

Statistical process control

CAPA

KPI tracking

Root cause analysis

Audit leadership

Cross-functional collaboration

Education

BS in Engineering

Tools

MS Office

Minitab

Job description

Senior Supplier Quality Engineer

Exton, PA

The Sr. Supplier Quality Engineer will support the biomedical group regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stakeholders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI’s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet dsm-firmenich expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team.

• Serve as primary quality contact with vendors of all sizes and complexities.
• Own and manage the supplier qualification process and Approved Supplier List.
• Develop, document, and implement QA Procedures.
• Analyze internal systems for improvement and drive the improvement efforts.
• Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required.
• Establish and negotiate Quality Agreements with required supply chain partners.
• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
• Prepare, review, and approve technical reports and provide recommendations based on data rationale.
• Develop, lead, and review root causes for non-conformances and deviations.
• Review documentation for completeness and accuracy.
• Complete other tasks and projects as assigned by the Supplier Quality Engineering Manager.
• Lead focused, multidisciplinary teams with clear objectives.
• Serve as leader, teacher, and mentor to other supplier quality team members.
• Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
• Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.

We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits
• A place to grow and develop.
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
• The opportunity to work on growing brands and build on a strong foundation.
• The chance to make improvements and make an impact on the business.

You Bring:

• BS Degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science or equivalent undergraduate experience.
• 8-12 years of Quality Engineering or Supplier Management at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
• Experience with animal tissue, collagen, resin/polymers ideal.
• Hands on experience with supplier and component qualification required.
• Well-developed interpersonal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments.
• Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.
• Lead auditor ISO 13485 certification required (practicing for a min of 5 years); Six Sigma, ASQ QE or CQA Certification a plus.
• Experience with 21 CFR820 required.
• Proficient in MS Office software including Word, Excel, and Outlook.
• Experience in statistical analysis (Minitab, Excel).
• Understanding of GMP and standards.

The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered willbebased on the applicant’s job-related skills, experience, relevant education, or training, and primary work location. Salary: $115,000.00 - $125,00.00.

In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage,paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.

About dsm-firmenich

At dsm-firmenich, we don’t just meet expectations – we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bringprogress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions – every single day. Whether it’s fragrancethat helps you focus, alternative meat that’s better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health,and beauty for everyone, everywhere. And while you’re making a difference, we’ll make sure you’re growing too. With learning that never stops, a culture that lifts youup and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They’re essential to our future. Because real progressonly happens when we go beyond, together.

Inclusion, Belonging and Equal Opportunity Statement

At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, theydo their best work – and that’s exactly the kind of culture we’re building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has thechance to grow, contribute, and feel they belong. We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair andinclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve. We welcomecandidates from all backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need anysupport through the application process, we’re here to help – just let us know what you need, and we’ll do everything we can to make it work.

Agency Statement

Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency’s fees, percentagesor similar.