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J&J Family of Companies Source Quality Specialist (m/w/d) 1 Jahr befristet in Germany

Source Quality Specialist (m/w/d) 1 Jahr befristet

Location: Umkirch

Johnson & Johnson is recruiting for a Source Quality Specialist, located in Umkirch, Germany.

The Site Quality Source Specialist serves as the on-site Johnson & Johnson Medical Devices (JJMD, hereafter represented by Synthes GmbH) quality representative for the Strategic Collaborator (SC). In collaboration with the SC, they will use quality principles and problem-solving skills to improve and maintain JJMD products and processes. They will support the SC quality engineering team on initiatives impacting JJMD products and processes, by providing guidance in risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Source Quality Specialist is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards.

Key Responsibilities:

  • Reviews and approves key quality records related to JJMD products in accordance to the Quality Agreement (QA) and Quality System Execution Plan (QSEP) as per Change Control process.

  • Coordinates JJMD review of Non-routine Rework and Use-As-Is nonconformance disposition in collaboration with other required JJMD functions.

  • Reviews high-risk CAPAs (i.e. Field Action, Critical Audit Observations, Major External Audit Observations, Near Misses and PRM).

  • Generates Non-Conformance Reports (NCR) in accordance to established procedures

  • Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD.

  • Supports improvement plans to address below-target metrics and negative trends.

  • Partners with SC on Recall Prevention.

  • Supports SC on External Audit Readiness initiatives.

  • Supports site closure product transfer activities as needed.

Qualifikationen

Education:

A Bachelor’s Degree is preferred, preferably in Engineering or related technical field.

Experience and Skills:

Required:

  • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

  • This position will require relevant experience working in manufacturing/operations.

  • Experience with a consistent track record of implementing appropriate risk mitigation.

  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.

  • The ability to perform "hands on" troubleshooting and problem solving is required.

  • Good technical understanding of manufacturing equipment and processes is required.

    Preferred:

  • Experience working in both an FDA and European regulatory environment

  • Solid understanding of statistical software packages is helpful with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise.

  • A thorough understanding of GMP/ISO regulations.

  • Advanced knowledge and shown leadership in the areas listed in the Major Responsibilities and Duties with the position.

    Other:

    Language requirements: German: Very Good, English: Good

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

    We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

    That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

    Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

    Severely disabled applicants will be given special consideration if they are equally qualified.

Primärer Standort

Deutschland-Baden Württemberg-Umkirch-

Andere Standorte

Europa/mittlerer Osten/Afrika-Deutschland-Baden Württemberg

Organisation

Johnson&Johnson Med GmbH (7930)

Funktion

Quality

Requisition ID

2105988148W

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