Quality Engineer IIExton, PA(Hybrid)The Quality Engineer II will support the business unit regarding 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:Develop, document, and implement QA ProceduresAnalyze non-conforming materials and returned goods and recommend disposition and corrective actionsCreate suitable data analysis tables and report findings based on statistical evidence and trending.Provide analytical investigations and develop root cause for non-conformances and deviationsDesign and specify gauging and test equipment for quality assurance functionsAnalyze data and generate summary reportsInterface with vendors and customers as requiredDevelop validation strategies for process validationWrite validation protocolsAssist in the performance of qualification and validation studiesCreate and/or process XCN’s, ECN’s, process routers, drawings and other written documentation in accordance with GMP requirements to support product development and manufacturing.Review documentation for completeness and accuracyComplete other tasks as assigned by the Quality Engineering Manager.We Bring:Recognition and celebration of your efforts and accomplishmentsOpportunities for growth and advancement for those who embrace innovation and take initiativeCustomer-first approach, working with world-renowned companies and brands to turn ideas into impactful solutionsOpportunity to build a career making a significant impact on billions of lives, with the freedom to shape your own pathResponsibility and accountability in living company values and driving sustainable solutionsSupportive environment where individuals are empowered to progress and contribute to meaningful changeYou Bring:BS Degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science or equivalent undergraduate experience2-6 years of Quality Engineering experience within a QA/QC department at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industryStatistical analysis techniques and software (i.e – Minitab).Understanding of GMP and standards.Experience in Biomaterials, Polymers, Chemistry or Biomedical Engineering.Knowledge of medically useful biomaterials (degradable and non-degradable) preferred.Knowledge of physical and chemical processing techniques. (ie- melt processing, compression molding, foaming, lyophilization, aseptic processing, cross-linking, sterilization) preferred.Good written and oral communications skillsAbility to lead and/or function as part of a teamComputer literacy (ie - Word, Excel, PowerPoint, Project, Power BI)ASQE Certification a plusdsm-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.dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, 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.About dsm-firmenichAs innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people. 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.