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Program Manager
Abbott Park, Illinois  |  Onsite
Contract Position
It appears that you have already applied to this job.
Applied on June 21, 2021
Job Id #48182 Posted June 8, 2021


RESPONSIBILITIES:

  • Responsible for oversight and in completion of case investigations, QIs and CAPA projects owned by Operations, assuring compliance, quality and timeliness of records.
  • Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
  • Independently investigate, gather data, and perform preliminary analysis.
  • Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
  • Lead meetings and communications for investigations, QI and CAPA updates, information, and concerns.
  • Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
  • Support Operations in the delivery and oversight of QI and CAPA training program.
  • Assist in the initiation, processing and completion of QI and CAPA records in the electronic system.
  • Execute and provide on-time completion of Quality Assurance deliverables.
  • Provide support and subject matter expertise during audits and inspections.
  • Lead and/or contribute to continuous improvement initiatives and projects.
  • Investigation and authoring of non-conformances and CAPAs
  • Developing and implementing process improvements
  • Participates in Quality Assurance Process Improvement Projects
  • Participates in client audits and regulatory inspections as needed

BASIC QUALIFICATIONS | EDUCATION:

  • Bachelor’s degree required and +2 years of related experience or 8+ equivalent years of related experience
  • Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies
  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • 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 organizational and follow-up skills, as well as attention to detail
  • Able to think strategically and independently

PREFERRED QUALIFICATIONS:

  • ASQ and PMI certifications
  • Six Sigma certified
  • Prior medical device software experience
  • Technical writing
COMPETENCIES
  • Vision
  • Communication
  • Critical Thinking
  • Negotiation
  • Problem-Solving
  • Diplomatic

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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