1+ months
2018-03-152018-05-13

Sr. Development Quality Engineer

Abbott
Scottsdale, AZ

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The Development Quality/Design Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system.  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.

Responsibilities:

  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of  Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional  root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support and ensure internal & external audit responses
  • Support and ensure on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable  customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
  • Lead meetings and communications for QA system information, concerns, and updates.
  • Lead and mentor others with QA data analysis, trending, and reporting.  High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Develop and lead other team members.
  • Perform other duties and responsibilities as assigned by management.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

    Qualifications:

    • Bachelor level degree in Engineering or Technical Field; Electrical Engineering degree preferred
    • 5+ years experience
    • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
    • Detailed knowledge of FDA, GMP, and ISO 13485
    • Solid communication and interpersonal skills
    • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
    • Advanced computer skills, including statistical/data analysis and report writing skills
    • Prior medical device experience preferred
    • ASQ CQE certification preferred
    • Design for Six Sigma and Critical to Quality training and experience preferred.
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Ability to leverage and/or engage others to accomplish projects.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
      Job Family: Operations Quality
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: Yes, 10 % of the Time
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Sr. Development Quality Engineer

Abbott
Scottsdale, AZ

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Sr. Development Quality Engineer

Abbott
Scottsdale, AZ
US

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