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Job ID:  42059
Date:  Apr 7, 2021
Job function:  Quality, SHE & Security
Experience level:  Experienced Hire
Business:  DSM Innovation Center

Quality Engineer II, Product Quality - Exton, PA

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 can offer you stunning science and innovation that inspires. You’ll help us build solutions for a better world.
 

Using a well performing Quality Management System, the Quality Engineering, Product Quality team supports the manufacture of DSM Biomedical products and materials and interfaces with our diverse customer partners.
 

DSM Biomedical is looking for a Quality Engineer II to support our Product Quality team and planned business growth. This position supports a diverse technology base in medical device production including finished goods in natural materials, polymer products, and bioceramics.
 

Quality Engineer II- Product Quality
Location: Exton, PA

 

Come join our team!  
 

You will be responsible to:

  • Serve as primary contact with business unit customers of all sizes within platform expertise; including communicating data, reports, conclusions, and changes.
  • Analyze non-conforming products and returned goods and recommend disposition and corrective actions.
  • Design, execute and report validations including Operational Qualifications (OQ), Process Qualifications (PQ), Measurement System Analysis, and Test Method Validations.
  • Create, assess, and process production documentation, test methods, product drawings, and other written documentation in accordance with GMP requirements to support product development and manufacturing.
  • As appropriate, work within design controls to assist product development activities. 
  • 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.  
 

At DSM, we Do Something Meaningful. 
 

What we look for in you:

  • BS Degree in Engineering discipline. 
  • ASQE or Six Sigma Black Belt Certification a plus.
  • 4-6 years Quality Engineering within a QA/QC department at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry. 
  • Perform validations on equipment in process, IO, OQ, PQ as well as use statistical techniques and software (i.e – Minitab).

 

The Reward

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.
 
Procedure & Contact

Interested 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.

DSM in 3 minutes

Do you know that DSM has the broadest portfolio of nutritional ingredients - that millions of people already have our biomaterials in their body - and that our innovations make materials lighter, healthier, safer, stronger, more durable and have a lower environmental footprint? This short 3 minute video shares our portfolio in Nutrition, Health and Sustainable Living