Job Number: 20013902

Locations:
Miami Lakes, FL
Milpitas, CA

Date Posted: 6-17-2017

Job Title: Manager New Product Development/New Business Development--Quality Engineering

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What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.

  • Demonstrates knowledge of quality systems and approaches.
  • Demonstrates an understanding of the relevant regulations, standards and operating procedures.
  • Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
  • Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
  • Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
  • Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Essential Duties and Responsibilities

  • Oversees the operation of the NPD/NBD Quality Engineering group.
  • Cooperates with other management personnel in formulating and establishing operating procedures, and goals.
  • Hires, trains and develops immediate staff to meet and exceed the current regulatory requirements, and proper procedures related to NPD/NBD QE activities. Ensures the adequacy of QA procedures and performance of QA staff.
  • Estimates budget for the NPD/NBD QE department and maintain operating costs within constraints of those budgets.
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for appraising performance, and addressing/resolving personnel problems.
  • Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
  • Ensures the development and continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes.
  • Ensures the organization is alerted to issues in time to resolve potential adverse effect.
  • Leads and manages the NPD/NBD quality engineering group to implement engineering and quality systems to meet regulatory compliance strategies and objectives.
  • Ensures effective technical design reviews and effective implementation and utilization of quality tools within research and development and new product development.
  • Monitors worldwide regulatory and technical standards environments for shift in design related quality trends.
  • Builds an organization of leading engineers to create effective quality engineering processes at all levels and throughout the engineering organization.
  • Guides high-level engineers in development and deployment of innovative quality engineering tools, techniques and systems that will drive product development to successfully achieve key business result.
  • Leads the NPD/NBD Quality Engineering Group in support of NPD/NBD Projects. Responsibilities of NPD QE include the following: Review/Approval of Characterization, Design Planning, Design Input, Design Output, Design Verification and Validation, Operational Qualification, Performance Qualification, Risk Management, Labeling Development, Competitive Testing, Design Transfer and Launch Planning. Responsibilities of NBD include Supplier Quality Agreements, Applicable Design Control Deliverables determination, Supply Chain and Launch Planning, DHF verification, Finished Device Qualification and Direct Ship Strategy as applicable.
  • Lead NPD/NBD Quality Engineering Group in support of Supplier Quality Agreements and Supplier Component Qualification and/or Finished Device Qualification during Pre-Launch phases.
  • Lead NPD/NBD Quality Engineering Group in data analysis support for R&D projects where applicable.
  • Support Complaints and Escalation or applicable CAPAs for recent project launches (pre-phase 6 closure)
  • Support Post Launch design and/or significant process change projects as applicable.
  • Support External Audits in areas of Design Control, Product Risk Management, and Recent Project Launches as applicable.
  • Responsible for acquiring and maintaining current knowledge of applicable Quality & Regulatory requirements and trends.
  • Talent Management (recruiting, hiring, termination, organizational design, performance management and leadership development) for their organization

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 8+ years experience in related field, preferred

What is expected of you and others at this level

  • Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
  • Participates in the development of policies and procedures to achieve specific goals
  • Ensures employees operate within guidelines
  • Decisions have a short term impact on work processes, outcomes, and customers
  • Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
  • Interactions normally involves resolution of issues related to operations and/or projects
  • Gains consensus from various parties involved

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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