Quality Systems Engineer

USA, Middletown,Delaware

The Datwyler Sealing Solutions Division is a leading supplier of bespoke sealing solutions to global market segments such as Healthcare, Automotive, Civil Engineering and Consumer Goods.  This is built on leading material, engineering and process know-how and the worldwide presence with own production locations. With a global manufacturing footprint, sales in over 100 countries and more than 5,000 employees, the company generates an annual revenue in excess of 500 million Euro.

We value our employees and encourage both personal and professional development.  Our advanced technology environment provides a challenging and satisfying work environment backed by our company values: Entrepreneurship, Respect, Excellence, and bring Value to our Customers.

Quality Systems Engineer

The position

Initially, the position will hold significant responsibility as part of greenfield project team to assist in the setup of a clean, pharma packaging manufacturing environment. Once the state of the art manufacturing facility is operational the incumbent will move into a quality systems position for the local operation.

Areas of responsibility
Documentation System: will provide interdepartmental assistance to ensure that controlled documents reflect current practice. This position will ensure proper document distribution and continually improve the flow of the documentation process. The Quality Systems Engineer will also create and review QMS documentation.

Internal Audits: will lead and audit team member activities included within the current year schedule. This position will create and implement an internal audit schedule.

Master listing Maintenance: will maintain the master listing of customer specifications, surveys, and Quality Agreements.

Training Curriculum Maintenance: will ensure that training records that are submitted match the required training list per job as defined by department managers.

Position Requirements: A Bachelor’s degree with 3-5 years’ experience is required. The ideal candidate will have experience in a regulated environment and strong technical writing/proofreading skills. An ISO 9001 Internal Auditor Certification and knowledge of ISO or GMP requirements for primary packaging materials or medicinal products is preferred.

We offer you the opportunity to utilize your work experience and implement your innovative ideas in a specialized, future-oriented company.  If you are interested in applying for this position please email your resume of qualifications to:  pharma_currentjobs.us@datwyler.com.



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