Development Quality Manager (Sylmar)

Abbott in Sylmar, CA

  • Type: Full Time
position filled
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Responsible for managing a Quality Group that supports development of mechanical circulatory support systems for patients with heart failure. Products include mechanical pumping systems, electronic controllers, power sources, and other devices for temporary and long-term management of heart failure. The position:

  • Plays a key role in establishing, planning and preparing design control deliverables for medical devices.
  • Manages human resources including setting performance goals, monitoring and reviewing performance, conducting performance appraisals, recommending staffing levels, and ensuring personnel development and training.
  • Manages employees who exercise significant latitude and independence.
  • Ensures implementation of quality policies, processes, and procedures of the design control subsystem. Defines, leads and prepares on-time completion of design control deliverables.
  • Leads and/or oversees risk management activities from product concept through commercialization.
  • Works closely with the research and development organization during the entire stage gate process to ensure product requirements meet customer expectations and potential product issues are identified and addressed in design.
  • Communicates effectively on project status, success and risks that could impact customer satisfaction or project objectives.
  • Strategizes and serves as a multi-disciplined thinker who develops proposals to address issues and resolve project risks.
  • Maintains development related documentation and establishes procedures that affect department and development processes.
  • Plans and initiates projects to improve process flows and identifies adequate control points.
  • Develops resource and budget plans for projects and is accountable for managing resources to achieve business objectives.
  • Position is a key interface between Quality and R&D organizations. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
  • Accountable for design verification and validation planning and execution, including active cross-functional root cause analysis investigation and resolution activities. Support design transfer including process validation activities.
  • Drive best practices for design test and inspection method development and lead method validation activities.
  • Complies with U.S. FDA regulations, other country regulations, consensus standards, company policies and procedures. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Minimum Qualifications: Bachelors degree in technical/scientific discipline; 6-10 years of experience preferably in quality/technical area of implantable medical devices; Demonstrated leadership experience through formal and informal assignments. Supervised technical personnel for at least 2 years. Strong knowledge of regulations and standards affecting medical devices.


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