Senior Quality Source Engineer
Johnson & Johnson Services, Inc
Balsthal, Switzerland
vor 5 Tg.

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Job Description

Caring for theworld one person at a time inspires and unites thepeople of Johnson & Johnson. We embrace research and science -

bringinginnovative ideas, products and services to advance the health and well-being ofpeople. Employees of the Johnson & Johnson Family of Companies work with partnersin health care to touch the lives of over a billion people every day,throughout the world.

This culture of caring is the focus of our corporatephilosophy, that are anchored in the internationally applicable Credo.

DePuy Synthes Companiesof Johnson & Johnson is the largest, mostcomprehensive orthopedic and neurological business in the world.

DePuy Synthesoffer an unparalleled breadth and depth of technology, devices, services andprograms in the areas of joint reconstruction, trauma, spine, sports medicine,neurological, cranio-

maxillofacial, power tools and biomaterials. Our broadarray of inspired, innovative and high-quality offerings, help advance thehealth and wellbeing of people around the world.

We are currently hiring a : Senior Quality Source Engineer Overview Located in the Manufacturing Site in Balsthal(SO) the Site Senior Quality Source Engineer act as on-

site Johnson &Johnson Medical Devices (JJMD) quality engineering representative for theStrategic Collaborator (SC). In partnership with the SC, he / she utilizesquality engineering principles and problem-

solving skills to improve and maintainJJMD products and processes, including validation, risk management, productquality issue resolution and critical issue, and quality systems performancemonitoring.

The Senior Quality Source Engineer is responsible for ensuring thatthe SC has a clear understanding and ability to execute to the JJMD / SC QualityAgreement requirements, J&J Policies, and applicable regulations andstandards.

Your Role You will bereviewing and approving key quality records as they related to JJMD productssuch as : Site ValidationMaster PlanValidation protocolsand reports per Change Control ProcessesHigh-

risk CAPAs(i.e., Field Action, External Observations)New or revisedinspection plans and associated sampling strategiesWhere necessary,collaborate with PSC in failure investigation and corrective action planningfor High-

  • Risk CAPAs (i.e. Field Action, External Observations) involving JJMDproducts.You will oversee thecoordination of JJMD review and approval of;
  • Non-routine reworkin collaboration with other required JJMD functions such as Design Quality,Product Management, and Sustaining EngineeringUse-

    as-IsNonconformance Disposition in collaboration with other required JJMD functionssuch as Regulatory Affairs and Medical AffairsSupport TechnicalAssessments in collaboration with SC site compliance, JJMD Supplier QualityCompliance, and JJMD Product Management.

    Partners with SCQuality Engineering, JJMD Medical Affairs, and JJMD R&D / PM in thedevelopment of Process Failure Mode Effects Analyses (pFMEAs) and correspondingControl Plans.

    Supports SC Qualityand Manufacturing Engineering on the resolution of quality issues impactingJJMD products and coordinates additional subject matter expert support neededfrom JJMD.

    Supports improvementplans to address below-target metrics and negative trends.Serves as the SiteLiaison’s deputy.Partners with SC onRecall Prevention and External Audit Readiness initiatives.

    Qualifications A minimum of a Bachelor’s Degree, preferablyin Engineering or related technical field. 4 / 6 years related experiencepreferred.

    Experienceworking in both an FDA and European regulatory environment is preferred.Thisposition will require relevant background in manufacturing / operations.

    In-depthknowledge of product / process Risk Management (FDA and ISO standards).Experiencewith a consistent track record of implementing appropriate risk mitigation.

    Technicaltraining and experience using Statistics, Lean and Six Sigma Methodologies isrequired including Measurement System Analysis, SPC, DOEs, Reliability, etc.

    Strongknowledge of statistical software packages is preferred with the ability topreview, graph and analyze data and be able to present data thatfacilitates / drives decision-

    making.Abilityto perform "hands on" troubleshooting and problem solving.Goodtechnical understanding of manufacturing equipment and processes is required.

    Understandingof the NPI (New Product Introduction) process and Process Validation expertiseis preferred.Athorough understanding of GMP / ISO regulations and validation regulations ispreferred.

    Advancedknowledge and shown leadership in the areas listed in the MajorResponsibilities and Duties with the position.Demonstratedproject management and project leadership abilities are required.

    QualityEngineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).BusinessFluent English and German required Areyou an experienced OH Physician with an international mindset and eye forbusiness?

    Do you feel attracted by a dynamic environment? Then please send usyour online application (CV, Motivation Letter, Working References etc.

    Johnson& Johnson Family of Companies are equal opportunity employers, and allqualified applicants will receive consideration for employment without regardto race, color, religion, sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteran status, disability status, orany other characteristic protected by law.

    Primary LocationSwitzerland-Solothurn-Balsthal-OrganizationSynthes GmbH (7111)Job FunctionQuality (Generalist)Requisition ID1905720714W

    Caring for theworld one person at a time inspires and unites thepeople of Johnson & Johnson. We embrace research and science -

    bringinginnovative ideas, products and services to advance the health and well-being ofpeople. Employees of the Johnson & Johnson Family of Companies work with partnersin health care to touch the lives of over a billion people every day,throughout the world.

    This culture of caring is the focus of our corporatephilosophy, that are anchored in the internationally applicable Credo.

    Caring for theworld one person at a time

    DePuy Synthes Companiesof Johnson & Johnson is the largest, mostcomprehensive orthopedic and neurological business in the world.

    DePuy Synthesoffer an unparalleled breadth and depth of technology, devices, services andprograms in the areas of joint reconstruction, trauma, spine, sports medicine,neurological, cranio-

    maxillofacial, power tools and biomaterials. Our broadarray of inspired, innovative and high-quality offerings, help advance thehealth and wellbeing of people around the world.

    We are currently hiring a :

    DePuy Synthes Companiesof Johnson & Johnson Senior Quality Source Engineer Overview

    Located in the Manufacturing Site in Balsthal(SO) the Site Senior Quality Source Engineer act as on-site Johnson &Johnson Medical Devices (JJMD) quality engineering representative for theStrategic Collaborator (SC).

    In partnership with the SC, he / she utilizesquality engineering principles and problem-solving skills to improve and maintainJJMD products and processes, including validation, risk management, productquality issue resolution and critical issue, and quality systems performancemonitoring.

    The Senior Quality Source Engineer is responsible for ensuring thatthe SC has a clear understanding and ability to execute to the JJMD / SC QualityAgreement requirements, J&J Policies, and applicable regulations andstandards.

    Your Role

  • You will bereviewing and approving key quality records as they related to JJMD productssuch as :
  • You will oversee thecoordination of JJMD review and approval of;
  • Support TechnicalAssessments in collaboration with SC site compliance, JJMD Supplier QualityCompliance, and JJMD Product Management.
  • Partners with SCQuality Engineering, JJMD Medical Affairs, and JJMD R&D / PM in thedevelopment of Process Failure Mode Effects Analyses (pFMEAs) and correspondingControl Plans.
  • Supports SC Qualityand Manufacturing Engineering on the resolution of quality issues impactingJJMD products and coordinates additional subject matter expert support neededfrom JJMD.
  • Supports improvementplans to address below-target metrics and negative trends.
  • Serves as the SiteLiaison’s deputy.
  • Partners with SC onRecall Prevention and External Audit Readiness initiatives.
  • Qualifications

  • A minimum of a Bachelor’s Degree, preferablyin Engineering or related technical field. 4 / 6 years related experiencepreferred.
  • Experienceworking in both an FDA and European regulatory environment is preferred.
  • Thisposition will require relevant background in manufacturing / operations.
  • In-depthknowledge of product / process Risk Management (FDA and ISO standards).
  • Experiencewith a consistent track record of implementing appropriate risk mitigation.
  • Technicaltraining and experience using Statistics, Lean and Six Sigma Methodologies isrequired including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Strongknowledge of statistical software packages is preferred with the ability topreview, graph and analyze data and be able to present data thatfacilitates / drives decision-making.
  • Abilityto perform "hands on" troubleshooting and problem solving.
  • Goodtechnical understanding of manufacturing equipment and processes is required.
  • Understandingof the NPI (New Product Introduction) process and Process Validation expertiseis preferred.
  • Athorough understanding of GMP / ISO regulations and validation regulations ispreferred.
  • Advancedknowledge and shown leadership in the areas listed in the MajorResponsibilities and Duties with the position.
  • Demonstratedproject management and project leadership abilities are required.
  • QualityEngineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
  • BusinessFluent English and German required
  • Areyou an experienced OH Physician with an international mindset and eye forbusiness? Do you feel attracted by a dynamic environment?

    Then please send usyour online application (CV, Motivation Letter, Working References etc.)

    Johnson& Johnson Family of Companies are equal opportunity employers, and allqualified applicants will receive consideration for employment without regardto race, color, religion, sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteran status, disability status, orany other characteristic protected by law.

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