Abbott

QA Director – Commercial and Affiliate

Abbott

full-time

Posted on:

Location Type: Hybrid

Location: Temecula • California • Massachusetts • United States

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Salary

💰 $149,300 - $298,700 per year

Job Level

Lead

About the role

  • Develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls.
  • Define and communicate overall vision and cascaded objectives for the departments.
  • Provides overall leadership for Quality policies, approaches, and standard practices.
  • Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
  • Responsible for AV Quality Commercial Excellence PMO, globally.
  • Oversight of quality practices for the commercial organization.
  • Development, implementation and maintenance of systems around commercial distribution of Vascular products.
  • Proactive approach ensuring all regulatory requirements and company QA policies and procedures are met.
  • Active participation on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations.
  • Key role in external inspections/audits that take place across commercial affiliates or Corporate Audit.
  • Support development and implementation of any required corrective action plans resulting from affiliate audits.
  • Providing high level direction of all activities related to calibration of measurement equipment used throughout the organization.
  • Assures Quality provides technical support and services to Operations and Research & Development functions.
  • Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations.
  • Champion of Quality, Lean and disciplined problem solving throughout the organization.
  • Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization.
  • Provide diligent and fact-based communication to Executive Management team, peers, and team.
  • Provide management and development of the Quality staff.
  • Be an effective member of the cross-functional Director organization to maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
  • Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements

  • Bachelor’s degree + 16 years experience
  • Minimum 10 years in quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
  • Demonstrated ability to understand/ familiarity with applicable FDA and TUV regulations, and other relevant clinical/regulatory requirements.
  • Class III or II medical device background in a Quality Leadership role.
  • Quality System Regulations knowledge (ISO 9001, ISO 13485).
  • Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
  • Strong organization, speaking skills, and influential management ability.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Benefits
  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
  • Free coverage applies in the next calendar year.
  • Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assuranceregulatory compliancequality management systemscalibration of measurement equipmentCAPALeanproblem solvingISO 9001ISO 13485FDA regulations
Soft Skills
leadershipcommunicationorganizational skillsinfluential managementteamworkgoal settingfeedbackmulti-taskingplanningaccountability