Quality Engineer II - Exton, PA

DSM – Bright Science. Brighter Living.™

Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 25,000 employees. The company is listed on Euronext Amsterdam.

More information can be found at www.dsm.com.

Are you an experienced Quality Engineer with chemical processing experience? Previous exposure to liquid reactors, bulk polymer processing and extrusion or pharmacuetical industry experience would be very helpful in this role. This valued resource would work cross-functionally with a variety of departments to lead qualifications through process development scale up activities.

The Challenge

To support the BU regarding engineering activities for all product lines; leading qualifications, designing, leading, and reporting 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.

The Position

* Expected to serve as primary contact with business unit customers of all sizes within platform expertise; including communicating data, reports, conclusions and changes.

* Develop, document, and implement QA Procedures.

* Analyze non-conforming products and returned goods and recommend disposition and corrective actions.

* Create suitable data analysis tables and report findings based on statistical evidence and trending.

* Design and specify gauging and test equipment for quality assurance functions

* Design own experimental work, analyze data and generate summary reports.

* Design, execute and report validations including Operational Qualifications, Process Qualifications, Measurement System Analysis and Test Method Validations.

* Review documentation and reports for soundness of technical judgement, accuracy and conclusions

* 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.

* Work within design controls to assist product development activities.

* Review new product designs (internal and external) and make recommendations for quality requirements.

* Plan, write and implement DOE's and test protocols required to evaluate new and existing products.

* 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.

The Ideal

* BS Degree in Engineering

* 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.

* Proficient use of 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)

* Working knowledge of analytical and mechanical test equipment.

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 on-line by sending us your resume and cover letter via the career portal (www.dsm.com/careers). Reference check procedures are part of the DSM Recruitment & Selection Process. You will be contacted when these references checks are required.

DSM Biomedical is a market leader in regenerative medicine and in the supply of biomaterials for medical devices. We have established a team of exceptionally talented and experienced individuals who are committed to innovation, collaboration and improving the medical professional and patient experiences. Our company possesses expertise in the research, development, scale-up and supply of novel materials and medical devices. This market is growing at a double digit rate and is characterized by long term commitment. Intellectual property is of paramount importance in this high value added market arena. DSM Biomedical is organized in several business units around a combination of technological platforms. These business units are regionally anchored and serve a global customer base. DSM Biomedical is part of the DSM Innovation Center and provides a proprietary product portfolio with coatings, drug delivery platforms 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 and pharmaceutical industries. The ultimate objective is to improve the outcome for patients. DSM's medical device expertise spans one of the broadest portfolios of medical materials, including biostable polyurethanes, ultra high molecular weight polyethylene's, resorb able polymers, ceramics, collagens, extracellular matrices, silicone hydrogels, device coatings, and drug delivery platforms. Millions of products are produced each year for applications in orthopedics, sports medicine, ophthalmology, general surgery and cardiology.

Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.

Royal DSM and its associated companies deliver annual net sales of about €10 billion with approximately 25,000 employees. The company is listed on Euronext. For more information about DSM see http://www.dsm.com or connect on