Staff Quality Engineer -CAPA

Johnson & Johnson
Published
September 11, 2019
Location
Jacksonville, FL
Category
Job Type

Description

Johnson & Johnson Vision Care, Inc., a member of the Johnson & Johnson Family of Companies, is hiring a Staff Quality Engineer to join its dynamic team located in its manufacturing site at its global headquarters in Jacksonville, FL.

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

This role provides quality leadership and support to business units. Leads root cause investigation activities and drives continuous improvements. The staff engineer is an emerging authority in the Business Unit quality management including non-conformance management, CAPA investigations and activity closure, validation documentation review and approvals, complaint investigations/trends, internal and external audits support etc.

You will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products within the business unit. The successful candidate will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business Unit vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes

Key Responsibilities:
Business Unit Support

  • Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management
  • This includes investigations related to NC’s and complaints, trending of same and assessing need for CAPA.
  • Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB
  • Support both Internal and External audits, act as Business Unit Subject Matter Expert

Business Improvements / Compliance/Regulatory

  • Lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
  • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
  • Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

Product Quality, Process Qualification Control & Disposition and Performance Standards

  • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  • Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  • Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
  • Approve IQ, OQ, PQ or TMV.

Production/Process Controls including Control Plans

  • Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
  • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

  • Partake in Change Request (CR) management for the Business Unit enduring appropriate and timely review and approval of CR’s in partnership with Business Unit peers.
  • Document, justify, review or analyse whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.
  • Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.

Strategic / People

  • Conduct strategic planning with business unit leaders.
  • Partnership with other functions to establish business priorities and resource allocation.
  • Ensures effective quality strategies are created for the validation of test methods, process and design.
  • Provides mentoring and coaching for others.
  • Provide peer feedback for performance evaluations and developmental plans of others.

Qualifications

Bachelor's Degree in Engineering, Life Science, Physical Science or a related field.

  • Minimum 6 years in a Quality Engineer or related work experience in FDA regulated industry for Medical Devices, Biologics, or Pharmaceuticals
  • Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
  • Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
  • Ability to demonstrate standards of leadership – Managing Complexity/Credo Values/Innovations/Customer focus.
  • Have computer skills including Power Point, Word, and Excel
  • Communicate effectively at all levels within Quality as well as cross functionally with departments such as Engineering, R&D, Operations, Purchasing, Compliance and Medical Affairs
  • Flexible
  • Team Player
  • Good Influencing Skills
  • Strong leadership, collaboration and influencing skills.
  • Be very familiar with the relevant regulatory standards (F.D.A. Quality System regulations, ISO-13485) applicable to the manufacture of Class III medical devices to Global markets.
  • Have experience with integrated/automated process - req

  Preferred:

  • Advanced Degree
  • Have ASQ certification (CQE, CQM, CRE or CQA)
  • Proven leadership and/or participation in campus/community service activities.

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.

       

Primary Location

United States-Florida-Jacksonville-

Organization

Johnson & Johnson Vision Care, Inc. (6094)

Job Function

Quality (Eng)

Requisition ID

2769190820

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