Senior Quality Assurance Engineer
hace 2 días
About the Role
Abbott Laboratories is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
This Senior Quality Assurance Engineer role is a key position within our organization, working closely with Manufacturing and Engineering teams to ensure compliance with quality system requirements and achievement of Key Performance Indicators (KPIs). The successful candidate will own/lead process/product validation activities, work with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities and during new product introduction, and be responsible for developing and maintaining quality engineering methodologies.
Main Responsibilities
- Verify company adherence to established Quality System and GMP/ISO standards.
- Completion of risk management and risk analysis including FMEA.
- Provide mentorship to lower-level engineering positions.
- Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
- Support technical and statistical investigations concerning optimization and compliance to specification.
- Owner of measuring process capability, process controls, and process validation/efforts.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
- Conducting & Own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process, Field Actions.
- Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
- Leading & Own Build At Risk (BAR) Authorizations & Closures.
- Own, complete Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Creation and maintenance of Quality Plans and Reports.
- Owning, Executing, and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications.
- Conducting Advanced Statistical Data Analyses using Minitab.
- Owning, create and authoring Master Validation Plans and Reports.
- Supports activities during preparation and execution of audits (External / Internal), functioning as SME for specific Quality activities.
- Lead, coach, and mentor non-exempt and entry level exempt personnel.
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- Communicating in a timely manner details and information of events related to quality to upper management.
- Leading and presenter on management meeting such as QDR, KPIs and Management Review.
About Us
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. As a Senior Quality Assurance Engineer at Abbott Laboratories, you'll have access to career development opportunities with an international company where you can grow the career you dream of. You'll also be part of a company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
About Your Background
We're seeking a highly motivated and experienced Senior Quality Assurance Engineer to join our team. The ideal candidate will have 3-5 years of experience in Quality engineering positions within areas related to Quality in medical devices, pharmaceutical, or high technology industry. They will have experience in conducting validations, qualifications, test methods or NCMRs, and experience with control of non-conforming material. A Bachelor's degree in Engineering, Quality, Chemical, STEM (Science, Technology, Engineering, Math), biomedical, or related fields is required. A Master's Degree in a position-related field is desirable.
Salary and Benefits
The estimated annual salary for this role is $95,000-$110,000. In addition to a competitive salary, we offer a comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off.
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