DSM Sr. Quality Engineer - Exton, PA in Exton, Pennsylvania
DSM – Bright Science. Brighter Living.™
Royal DSM is a global, purpose-led, science-based company active in Nutrition, Health and Sustainable Living. DSM’s purpose is to create brighter lives for all. DSM addresses with its products and solutions some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. DSM delivers innovative solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company was founded in 1902 and is listed on Euronext Amsterdam.
More information can be found at www.dsm.com.
We are#hiring The Sr. Quality Engineer will support our Innovation team and focus on early process development. These project based deliverables include qualifying and validating new suppliers to ensure compliance and smooth running of processes. This individual will be well versed in design controls, process validation and root cause analysis.
We can offer you stunning science and innovation that inspires. You’ll help us build solutions for a better world.
Sr. Quality Engineer Location: Exton, PA
Join our dynamic team and play your part!
You will be responsible to:
To support the business unit regarding engineering activities for all new product development for all root cause analysis, qualifications, validations, data analysis and statistical process control.
Develop, document, and oversee the Validation Master Plans for new products.
Create suitable data analysis tables and report findings based on statistical evidence and trending.
Serve as a primary contact with external customers to develop qualification plans in accordance to applicable procedures.
Complete Supplier Quality Qualification activities during new product introduction.
Lead and/or support suppliers through execution of component deliverables as specified per PPAP and supplier audits.
Review new product designs (internal and external) and make recommendations for quality requirements.
Work closely with internal teams to coordinate, plan, and execute project requirements. Under guidance, lead multidisciplinary teams.
Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.
Get the reward to match your passion
Working for DSM means the opportunity to really contribute to improve people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance.
What we look for in you:
BS degree in Sciences or Engineering.
ASQE or Six Sigma Black Belt Certification a plus.
8 or more years Quality Engineering within a FDA-Regulated, Medical Device, Pharmaceutical, Biotech or other regulated industry.
Supplier evaluation experience.
Proficient use of statistical techniques and software.
Accomodate travel of 10%.
The RewardWorking for DSM means the opportunity to really contribute to improve people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance. Procedure & ContactInterested in this position? Please apply online via the career portal (https://jobs.dsm.com/). Pre-employment screening procedures are part of the DSM Recruitment & Selection Process. You will be contacted when further information is required. DSM Biomedical develops novel materials-based solutions to meet the present and future needs of the medical device industry. The company’s product portfolio includes coatings, drug delivery platforms, mechanical devices, and a wide range of biomedical materials that enable the replacement, repair, enhancement and the regeneration of tissue and organ functions in the body. Its novel materials-based solutions are designed to meet the needs of the medical device industry. The biomedical market is highly innovative and dynamic. https://www.dsm.com/corporate/about/businesses/dsm-biomedical.html
DSM NA is an Equal Opportunity and Affirmative Action Employer. DSM is committed 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.
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