Quality System Supervisor
Johnson & Johnson Services, Inc
Le Locle, Switzerland
vor 8 Tg.

Job Description

Caring for the world oneperson at a time inspires and unites the people of Johnson &Johnson. This culture of caring is the focus of our corporate philosophy, thatare anchored in the internationally applicable Credo.

DePuySynthes Companies of Johnson& Johnson is the largest, most comprehensive orthopedic and neurologicalbusiness in the world.

DePuy Synthes offer an unparalleled breadth and depth oftechnology, devices, services and programs in the areas of jointreconstruction, trauma, spine, sports medicine, neurological,cranio-

maxillofacial, power tools and biomaterials. Ourbroad array of inspired, innovative and high-quality offerings, help advancethe health and wellbeing of people around the world.

For our production site, weare looking for a highly committed : Quality System Supervisor basedin Le Locle (Permanent) Further responsibilities and duties are Responsible forthe consistent and correct execution of QS procedures at the site to ensure thequality and compliance of processes and records for NC, CAPA, IA Observations,Site Complaint Manufacturing Investigations, Product Quality Escalation, QPRand QSMR, reporting and tracking Stop Shipments.

Developscompetency of resources at the site that execute NC, CAPA, IA Observations,Site Complaint Manufacturing Investigations, Product Quality Escalation, QPRand QSMR, reporting and tracking Stop Shipments by providing training andguidance on the execution and documentation of these processes.

Responsiblefor the timely and compliant execution of site NCs, CAPA, IA Observations, SiteComplaint Manufacturing Investigations, Product Quality Escalation, QPR andQSMR, reporting and tracking Stop Shipment by championing cross-

collaborationacross functions, sites, and operating companies; identifying barriers for theprogress; and elevating issues for resolution.

Manageson-site QPR and QSMR, including coordination, preparation, execution, andtracking of activities.ManagesProduct Quality Escalations for nonconformances or issues originating at thesite, including the initiation, escalation, coordination, tracking, and closureof activities.

Manages onsite the timely collection, escalation and reporting of all Quality Systemmetrics to management.Maintainsoriginal documentation for site NC, CAPA, IA Observations, Site ComplaintManufacturing Investigations, Product Quality Escalation, QPR and QSMR asquality records, reporting and tracking Stop Shipment.

Identifiessite needs to meet and improve system performance of NC, CAPA, IA Observation,Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR andQSMR at the site level, and escalates to appropriate representative andmanagement in a timely manner.

Collaborateswith Franchise Quality in the deployment (design, implementation, andpost-monitoring) of QS initiatives impacting the site that promote thecontinuous improvement of the QS and ensure continuity of the application ofglobally shared processes and systems at site level.

  • Supportscompliance activities by participating in audit readiness; assists in Internaland External audits; serves as Subject Matter Expert for NC, CAPA, IAObservation, Site Complaint Manufacturing Investigation, Product QualityEscalation, Document Control, QPR and QSMR processes during audits;
  • manages theinvestigation, response, and remediation of site-specific QS audit observations.Oversees onsite Document Control (as required), including management of changedocumentation, on-

    site administration of the change control system, andarchival of documents on site.OtherQuality Systems assignment, tasks, responsibilities, and projects as assigned.

    QualificationsUniversity / Bachelor’sDegree or Equivalent.Degree in Engineeringis preferred or associated relevant Scientific / Technical / Quality discipline.

    Six (6) years relatedexperience in Medical Device or Pharmaceutical environment, or equivalentcombination of education and experience is required.

    Experience in workingin a manufacturing / operations environment is preferred.Knowledge of ISO andQSR regulations is required.

    Experience in QualityAuditing and notified body inspections is preferred.Experience with rootcause investigation, change management, risk management and technical writingis required.

    Experience in QualitySystems process development, support, integration or enhancement is preferred.Experience in ProjectManagement is preferred.

    A Certification inprocess excellence is preferred.Advanced use ofcomputer and software applications is required.Experience withtraining or coaching others is required.

    Direct supervisionexperience is preferred.Strong communication,influencing and leadership skills : ability to communicate at all levels of theorganization, and to interact with and influence cross-

    functional andcross-business teams to drive results is required. Strong businessacumen, interpersonal skills relating to teams with diverse cultures andbusiness practices is required.

    Strong verbal andwritten communications skills for multi-level stakeholders.Strategic andtactical execution abilities, including strong organization skills is required.

    Ability to takeinitiative regarding innovative approaches to problem solving in a fast paced,changing business environment is required.

    Ability to applyprinciples of logical or scientific thinking, root cause and statisticalanalysis. Ability to analyze,graph, and present data in a way that facilitates and drives decision making.

    Strong verbal andwritten Presentation Skills.Language : French : fluent / English : Business fluent. If you want to be a change agent in a challengingenvironment and shape the future quality organization, please send us youronline application (CV, Motivation Letter, Working References etc.

    Primary LocationSwitzerland-Neuchâtel-Le Locle-OrganizationMedos International Sarl (7898)Job FunctionQuality SystemsRequisition ID1905739231W

    Caring for the world oneperson at a time inspires and unites the people of Johnson &Johnson. This culture of caring is the focus of our corporate philosophy, thatare anchored in the internationally applicable Credo.

    DePuySynthes Companies of Johnson& Johnson is the largest, most comprehensive orthopedic and neurologicalbusiness in the world.

    DePuy Synthes offer an unparalleled breadth and depth oftechnology, devices, services and programs in the areas of jointreconstruction, trauma, spine, sports medicine, neurological,cranio-

    maxillofacial, power tools and biomaterials. Ourbroad array of inspired, innovative and high-quality offerings, help advancethe health and wellbeing of people around the world.

    For our production site, weare looking for a highly committed :

    Quality System Supervisor basedin Le Locle

  • Responsible forthe consistent and correct execution of QS procedures at the site to ensure thequality and compliance of processes and records for NC, CAPA, IA Observations,Site Complaint Manufacturing Investigations, Product Quality Escalation, QPRand QSMR, reporting and tracking Stop Shipments.
  • Developscompetency of resources at the site that execute NC, CAPA, IA Observations,Site Complaint Manufacturing Investigations, Product Quality Escalation, QPRand QSMR, reporting and tracking Stop Shipments by providing training andguidance on the execution and documentation of these processes.
  • Responsiblefor the timely and compliant execution of site NCs, CAPA, IA Observations, SiteComplaint Manufacturing Investigations, Product Quality Escalation, QPR andQSMR, reporting and tracking Stop Shipment by championing cross-
  • collaborationacross functions, sites, and operating companies; identifying barriers for theprogress; and elevating issues for resolution.

  • Manageson-site QPR and QSMR, including coordination, preparation, execution, andtracking of activities.
  • ManagesProduct Quality Escalations for nonconformances or issues originating at thesite, including the initiation, escalation, coordination, tracking, and closureof activities.
  • Manages onsite the timely collection, escalation and reporting of all Quality Systemmetrics to management.
  • Maintainsoriginal documentation for site NC, CAPA, IA Observations, Site ComplaintManufacturing Investigations, Product Quality Escalation, QPR and QSMR asquality records, reporting and tracking Stop Shipment.
  • Identifiessite needs to meet and improve system performance of NC, CAPA, IA Observation,Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR andQSMR at the site level, and escalates to appropriate representative andmanagement in a timely manner.
  • Collaborateswith Franchise Quality in the deployment (design, implementation, andpost-monitoring) of QS initiatives impacting the site that promote thecontinuous improvement of the QS and ensure continuity of the application ofglobally shared processes and systems at site level.
  • Supportscompliance activities by participating in audit readiness; assists in Internaland External audits; serves as Subject Matter Expert for NC, CAPA, IAObservation, Site Complaint Manufacturing Investigation, Product QualityEscalation, Document Control, QPR and QSMR processes during audits;
  • manages theinvestigation, response, and remediation of site-specific QS audit observations.

  • Oversees onsite Document Control (as required), including management of changedocumentation, on-site administration of the change control system, andarchival of documents on site.
  • OtherQuality Systems assignment, tasks, responsibilities, and projects as assigned.
  • University / Bachelor’sDegree or Equivalent.
  • Degree in Engineeringis preferred or associated relevant Scientific / Technical / Quality discipline.
  • Six (6) years relatedexperience in Medical Device or Pharmaceutical environment, or equivalentcombination of education and experience is required.
  • Experience in workingin a manufacturing / operations environment is preferred.
  • Knowledge of ISO andQSR regulations is required.
  • Experience in QualityAuditing and notified body inspections is preferred.
  • Experience with rootcause investigation, change management, risk management and technical writingis required.
  • Experience in QualitySystems process development, support, integration or enhancement is preferred.
  • Experience in ProjectManagement is preferred.
  • A Certification inprocess excellence is preferred.
  • Advanced use ofcomputer and software applications is required.
  • Experience withtraining or coaching others is required.
  • Direct supervisionexperience is preferred.
  • Strong communication,influencing and leadership skills : ability to communicate at all levels of theorganization, and to interact with and influence cross-
  • functional andcross-business teams to drive results is required.

  • Strong businessacumen, interpersonal skills relating to teams with diverse cultures andbusiness practices is required.
  • Strong verbal andwritten communications skills for multi-level stakeholders.
  • Strategic andtactical execution abilities, including strong organization skills is required.
  • Ability to takeinitiative regarding innovative approaches to problem solving in a fast paced,changing business environment is required.
  • Ability to applyprinciples of logical or scientific thinking, root cause and statisticalanalysis.
  • Ability to analyze,graph, and present data in a way that facilitates and drives decision making.
  • Strong verbal andwritten Presentation Skills.
  • Language : French : fluent / English : Business fluent.
  • If you want to be a change agent in a challengingenvironment and shape the future quality organization, please send us youronline application (CV, Motivation Letter, Working References etc.).

    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.

    Equal Employment Opportunity PostersIf you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please complete the form below.

    If you’d like to view a copy of the company’s affirmative action plan, please complete this form.This site is governed solely by applicable U.

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