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Design Engnieer

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Design, Engineering, Engineer

Projektbeschreibung

A newly FDA approved class III device company is rapidly growing their team with the exciting prospects of commercial production.

They are looking for innovative and creative quality engineers for long term contract opportunities to help with the fascinating future of the company.

If you fit the below requirements and are interested in learning more abou this exciting and groundbreaking company, please forward your resume immediately for consideration.

Essential Duties and Responsibilities:

Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods products. Enlists appropriate engineering or technical assistance to develop adequate inspection criteria, if needed. Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action. Identify opportunities, coordinates development of criteria and documentation, to facilitate suppliers' performance of quality inspections.
Evaluate and qualify Suppliers to ensure technical and quality requirements can be met. Manage corrective actions, rework plans and non-conformances. Provide suppliers with inspection criteria prior to manufacturing. Manage process validations and process improvements. Evaluate suppliers as part of due diligence in acquisitions.
Contribute to Design Control activities such as specification development, design verification and validation and audit of DHFs. Lead Risk Management activities. Develop and review Sterilization, Packaging, and Equipment Validations.
Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products
Support Non-Conforming Material Program.
Assist CAPA program with analysis and efforts relative to product quality issues. Identify and trend quality issues. Support analysis of CAPA Program data and identify/trend quality issues.
Support the analysis and presentation of information to executive management concerning measures of product and service quality, supplier performance, manufacturing problems, and design issues as identified through various quality systems program elements..
Other functions include:
8.1. Review technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.
8.2. Attend such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of the company.
8.3. Support other work of the Q.E. Department, as required.

Required Experience

Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience: Requires a bachelor degree in an engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME). Five years minimum experience in a regulated environment in Quality Assurance and or Manufacturing / Engineering (design) environment required (QSR, ISO 13485, and the MDD). American Society for Quality Certified Engineer (CQE) desirable.

KEYWORDS: quality or quality engineer or FDA or iso 13485 or iso 14971 or medical device, design controls, or designTo find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    San Diego, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland