Quality Engineer I Pennsylvania

Company: Fortitech Inc.
Location: Exton
Posted on: September 16, 2023

Job Description:

About dsm-firmenich

As 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.www.dsm-firmenich.com

You 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.

Responsibilities:

Develop, document, and implement QA Procedures.
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.
Design and specify gauging and test equipment for quality assurance functions.
Analyze data and generate summary reports.
Interface with vendors as required.
Write validation protocols; review documentation for completeness and accuracy.
Assist in the performance of qualification and validation studies.
Work on occasion in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
Report any observed unsafe equipment, condition or practice immediately to a supervisor, management, or member of the Safety Committee.
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 Quality, Science, or Polymer Engineering or equivalent undergraduate experience.
ASQE Certification a plus.
0-3 years Quality Engineering within a QA/QC department at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
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.
Experience with ISO 9001, or ISO 13485, or 21 CFR820 desired.
Proficient in MS Office software including Word, Excel, and Outlook.
Experience in Polymers, Chemistry or Biomedical Engineering preferred

Equal Opportunities Commitment:

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.

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.

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.

Keywords: Fortitech Inc., Lower Merion , Quality Engineer I Pennsylvania, Engineering , Exton, Pennsylvania