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Sr. Product Development Quality Engineer / Manager

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Engineering, Design, Engineer

Projektbeschreibung

Responsibilities:

* Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
* Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
* Support process validation programs for new product development.
* Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
* Provide input throughout the new product development process from a quality perspective.
* Perform risk analysis and develop mitigation strategies
* Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
* Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
* Perform supplier development activities surrounding PPAP
* Develop and create procedures for incoming, in-process, and final inspections for new product development
* May conduct internal Quality system audits and be involved with CAPA projects.
* May have involvement in training others on QA topics.

Requirements:

* Must be able to generate and explain detailed proposals, guidelines, and procedures for the QA function to departmental and/or non-departmental personnel.
* Must be able to analyze and resolve non-routine product issues using independent judgment.
* Must be able to routinely make decisions that affect immediate operations and may have a company-wide effect.
* Must be able to observe and correct minute inconsistencies (e.g. in the printed word, a production process, product appearance, etc.)
* Must be able to plan, organize, and implement multiple, concurrent tasks.
* Must be able to complete and/or review detailed documentation accurately and compliantly
* Must be able to assess a situation, gather the necessary facts and couple it with prior experiences and knowledge, to make decisions on how to move forward toward the ideal solution.

Qualifications:

* Bachelors Degree in Engineering or a related Life Sciences discipline
* 3+ years experience in an engineering/manufacturing environment or in quality engineering role in a regulated environment
* Experience with medical device development and manufacturing
* Experience in a Quality role familiar with FDA and ISO requirements.
* Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications
* Excellent analytical and problem solving skills
* Excellent interpersonal skills
* Excellent organizational skills
* Process validation experience; preferred knowledge of GHTF approach to validation
* Working knowledge of FDA, ISO, and other regulations and standards
* ASQ Certifications (CQE, CRE, CQM, CSSBB)

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland