Senior Quality Engineer - Exton, PA
dsm-firmenich
**Senior Quality Engineer**
**Exton, PA (Hybrid)**
The **Senior Quality Engineer** will support 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.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
**Key Responsibilities:**
+ Responsible for product-related root cause analysis, process mapping and impact assessments for change control. 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
+ Conduct statistical analysis and support key customer accounts as Quality Lead
+ Assist in the performance of qualification and validation studies
+ Assist with product development and in the transition of development products and projects
+ Review new product designs (internal and external) and make recommendations for quality requirements
+ Plan, write and implement DOE’s and test protocols required to evaluate new and existing products
+ Evaluate, identify and implement QA improvements to existing processes or products
**We Bring:**
+ Opportunities for growth and advancement for those who embrace innovation and take initiative.
+ Customer-first approach, working with world-renowned brands to turn ideas into impactful solutions.
+ Supportive environment where individuals are empowered to progress and contribute to meaningful change.
+ Recognition and celebration of your efforts and accomplishments.
+ Collaboration with in-house industry experts and access to a world-class portfolio of core ingredients.
+ Opportunity to take a proactive role in crafting the next generation of ingredient innovations.
**You Bring:**
+ BS Degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science or equivalent undergraduate experience.
+ 2-6 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.
+ Experience in statistical analysis (Minitab, Excel).
+ Experience with ISO 9001, ISO 13485, or 21 CFR820 required.
+ Understanding of GMP and standards.
+ Proficient in MS Office software including Word, Excel, and Outlook.
+ Excellent organizational, leadership, decision-making, and analytical skills.
+ Excellent written and verbal communication skills, including writing, editing and proofing skills.
+ 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.
dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.
As a committed equal opportunity employer, we ensure our recruitment practices are inclusive and fair. We encourage the recruitment of a diverse workforce, representative of the communities in which we work, by using inclusive language, diverse interview panels, diversified sourcing strategies. Selection is based on qualifications, competency, experience, performance history and fit with the team to advance fair and equitable opportunity.
Employment decisions are based upon job-related reasons regardless of an applicant's race, color, ethnicity, national origin, religion, gender, gender identity or expression, sexual orientation, age, disability, backgrounds, genetic information, protected veteran status, or any other status protected by law.
We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.
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, percentages or similar.
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