Lead Expert Quality Engineer - Exton, PA

Lead Expert Quality Engineer

Location: Exton, PA

About the Role

The Lead Expert Quality Engineer will support our Biomedical division with engineering activities for all product lines; qualifications, validations, data analysis, statistical process control (SPC), CAPA, KPI’s, Review, and Trending. Responsible for product-related root cause analysis, process mapping and impact assessments for change control. The Lead Expert Quality Engineer will operate closely with Customers, QA, QC, business managers, project managers, Manufacturing, and all other functionalities to assure QE objectives.

Key Responsibilities

• Provide leadership, guidance, and decision making for quality engineering deliverables
• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
• Create suitable data analysis tables and report findings based on statistical evidence and trending.
• Provide analytical investigations and develop root cause for non-conformances and deviations
• Analyze data, generate summary reports and write protocols for investigative and validation purposes
• Review new product designs (internal and external) and make recommendations for quality requirements
• Monitor processing, assembly, secondary operations and packaging operations for the purpose of improving efficiency/ process improvement and troubleshooting.
• Plan, write and implement DOE’s and test protocols required to evaluate new and existing products.
• Assist with product development and in the transition of development products and projects.
• Develop validation strategies for process validation
• Design and specify gauging and test equipment for quality assurance functions
• Interface with vendors as required
• Evaluate, identify and implement QA improvements to existing processes or products.
• Review documentation for completeness and accuracy
• Assist in the performance of qualification and validation studies
• 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 experience within a QA/QC department at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
• Experience in Biomaterials, Polymers, Chemistry or Biomedical Engineering preferred.
• ASQE Certification a plus.
• Well-developed inter-personal 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.
• Experience with ISO 9001, ISO 13485, or 21 CFR820 required.
• Proficient in MS Office software including Word, Excel, and Outlook; experience in statistical analysis (Minitab, Excel).
• Understanding of GMP and standards.

Salary

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 will be based on the applicant’s job-related skills, experience, relevant education, or training, and primary work location. Salary: $87,000.00 - $108,000.00.

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 bring progress 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 fragrance that 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 you up 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 progress only 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, they do 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 the chance 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 and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve. We welcome candidates 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 any support 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

We’re managing this search directly at dsm-firmenich. If you’re applying as an individual, we’d love to hear from you. We’re not accepting agency submissions or proposals involving fees or commissions for this role.