Quality Engineer IV at Abbott

Title: Quality Engineer IV

Location: Santa Clara, CA

Duration: 12 Months

Job Description

• Must have medical device.
• Familiar with regulations for Regulatory Affairs Someone who can hit the ground running or have supported the overall quality system.
• This role supports audits for the organization.
• Bachelor's degree 7+ years experience.
• Her team is rather unique.
• They are part of the Regulatory Affairs organization.
• They support their RA organization and their business unit from a quality and compliance perspective.
• Looking for someone with quality systems experience who has senior level expertise.
• Activities they do is supporting audits for RA manage all CAPA's for RA organization.
• Key task for this role is putting together a KPI dashboard maintaining that from a compliance perspective to keep a pule on metrics that they have.
• Highlight risks if they see them and put in mitigation plans before they become audit findings or nonconforming results in CAPA related activities.
• Her team specifically is operations they do not work on submissions this is why is a QE role and not a RA role.
• Supports management and creation of the processes that allows the RA specialist to execute those submission requirements.
  
  

Soft Skills

• Independent good clear communication skills, team player, there will be a lot of international cross function interactions.
• Good project management skills.
• Problem solving expertise.
  
  

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)
  
  

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.