“Johnson & Johnson companies are equal opportunityemployers” The Global Job Postingpolicy promotes the commitment to the advancement and development of ouremployees. We invite you to read this posting and apply if you areinterested in the position and meet the requirements.
Ethicon, Inc., a Johnson& Johnson company, is a trusted, world-wide leader in medical devicescompany who contributes to the advance surgery and improves lives everyday. We are qualified as one of the top best places to work. JoiningETHICON is more than joining a great company, it means being a part of a legacyof innovation, development and philanthropy. For more information,visitwww.ethicon.com
Searchingthe best talent for:QUALITY SYSTEMS MANAGER
Leadquality systems and compliance improvement, which result from Internal /External Audits, Management Review and / or any other CAPA / NCR systemindicator.
·Know and follow EES policies and procedures; ensure that directreports know and follow EES policies and procedures related to work activitiesperformed in area of responsibility
·Complete training in area of responsibility and ensure that directreports are trained in area of responsibility within allowed time-period. Training is required for changes in existingpolicies and procedures, for new assignments and for implementation of newpolicies and procedures. Completerequired periodic re-training and ensure that required periodic re-trainingtakes place for direct reports in areas such as safety and environmental
·Set standards for safe behavior.Recognize and reward safe behavior in others. Ensure that direct reports employ safepractices. Enforce safety policies &procedures. Evaluate staff member’ssafety performance and ensure that safety is a part of each direct report’sGPMS. Provide resources (time and money)necessary to maintain safety process.Ensure safety structure is in place in form of working committees anddepartment coordinators
·Manage the NCR and CAPA processes and systems for the sites.
·Represent the sites on the world-wide NCR and CAPA teams.
·Work effectively with other NCR / CAPA site leaders to ensureconsistent systems and processes at Ethicon plants.
·Drive the improvement and development of NCR and CAPA system forthe facilities.
·Responsible for the overall management and effectiveness of theNCR and CAPA processes, including leading and facilitating of relevant datareview forums.
·Provide education and mentoring as needed regarding NCR and CAPA(beginners and continuous education).
·Develop and implement measures to monitor the effectiveness of theNCR and CAPA systems.
·Lead quality systems and compliance improvement, which result fromInternal / External Audits, Management Review and / or any other CAPA / NCRsystem indicator.
·Serves as the initial point of contact for Product Complaints /Product Quality issues and ensures Risk Assessment is timely and adequatelyaddressed.
·Support sites risk management process.
·Oversees the complaint product evaluations activities for the sitesand maintains track and trending of product performance / results of productevaluations for escalation to CAPA.
·Establishes and maintains objectives, programs, procedures andcontrols to support the quality policy and mission.
·Oversee capital related projects and monitor controllable spendingfor the department.
·Bachelor degree in engineering- mechanical, electrical, industrial, preferred or Applicable science or business degree
·QSR, ISO and other regulatory requirements knowledge, required.
·Generally requires (8-10) years related experience
KEY SKILL / KNOWLEDGE REQUIREMENTS:
·Bilingual: English/ Spanish preferred
·QSR/ ISO knowledge preferred
·Experience Leading CAPAs, preferred
·Green or Black Belt Certification highly desired.
·Experience with external auditing bodies, preferred.
Three to five years in-process Quality Assurance experience in a manufacturing environment preferably in the medical industry or ISO regulated environment, **or equivalent degree.
·Sitting at a computer
·Light office work
·Using the telephone
·Walking, standing, bending and reaching standing.
·Lift up to 30 lbs occasionally
Global Leadership Profile Competencies:
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.
If you want to apply to this position, please consider the following information from our Global Job Posting Policy
•The employee has spent at least 18 months in his/her current position, and
•The employee is in good standing.
•Manager Notification - An employee may apply for a position without informing his/her manager. However, if the employee is invited to interview for a position, then, to the extent that this is consistent with local law or practice, s/he is required to notify his/her manager prior to the interview. This notification is encouraged to promote development discussions between the manager and the employee.
Refer an external candidate
If you want to refer an external candidate for this position, please review our Global Referral Policy and submit your referral throught My Next Step by following the appropriate process.
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