Quality Engineer II, New Process Introduction (NPI)Exton, PAHybrid - In Office 3 Days a week (subject to change)The Quality Engineer II, New Process Introduction (NPI) willsupport 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 controls.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 business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
Key Responsibilities: - Develop, document, and oversee the Validation Master Plans for new products.
- Review Operational and Performance Qualification (POQ and PQ) protocols.
- Experience with Design Controls.
- Create suitable data analysis tables and report findings based on statistical evidence and trending.
- Interact with external customers to develop qualification plans in accordance to applicable procedures.
- Analyze data and generate summary reports.
- Complete Supplier Quality Qualification activities during new product introduction.
- Lead and/or support suppliers through execution of component deliverables as specified per PPAP.
- Lead and/or support supplier audits.
- Review documentation for completeness and accuracy.
- Create and/or review XCN's, ECN's, process routers, drawings and other written.
- Develop, document, and implement QA Procedures.
- Design and specify gauging and test equipment for quality assurance functions.
- Report any observed unsafe equipment, condition or practice immediately to a supervisor, management, or member of the Safety Committee.
- Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
- Provide analytical investigations and develop root cause for non-conformances and deviations
- Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.
- With guidance, lead multidisciplinary teams to complete QE new product introduction activities.
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 Quality, Science, or Polymer Engineering or equivalent undergraduate experience.
- 2-6 years Quality Engineering within a QA/QC department at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
- Good written and oral communications skills
- Ability to lead and/or function as part of a team.
- Computer literacy (ie - Word, Excel, PowerPoint, Project)
- Statistical techniques and software (i.e - Minitab)
- Understanding of GMP and standards.
- Knowledge of medically useful biomaterials (degradable and non-degradable)
- Knowledge of physical and chemical processing techniques. (ie- melt processing, compression molding, foaming, lyophilization, aseptic processing, cross-linking, sterilization)
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.