Quality Engineer
Abbott
Date: 14 hours ago
City: Taguig
Contract type: Full time
Main Responsibilities
Minimum Education
Bachelor's Degree (Engineering/Life Sciences)
Experience
Requires 3-5+ years of quality experience to develop the competence to meet the skills and responsibilities of the position. Related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work
- Implement improvements to Quality Systems and tools by collecting data, conducting gap assessments, and presenting concise solutions.
- Investigate issues related to Complaint Management and Quality Systems, performing root cause analysis using the DMAIC process and available quality tools.
- Take ownership of non-conformance and Corrective and Preventive Actions (CAPA), documenting investigations and conducting periodic monitoring in accordance with procedures in a timely manner.
- Utilize quality tools to assess issues and escalate them through appropriate channels. This may involve the use of Failure Modes and Effects Analysis (FMEA), risk assessments, and other relevant tools.
- Provide support to internal and external audits. Manage relevant audit findings and CAPAs.
- Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with key stakeholders and Abbott business units.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Lead and/or participate in technical projects with inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
- Lead and/or participate on cross-functional teams to support organizational goals.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. may interface with external firms or agencies.
- Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).
- Identifies, develops and implements processes to improve department/ Team performance.
- Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
- Support project planning and perform assessments and mitigations with cross functional teams. Develop and manage training programs including training material and training audience. Track and report metrics.
Minimum Education
Bachelor's Degree (Engineering/Life Sciences)
Experience
Requires 3-5+ years of quality experience to develop the competence to meet the skills and responsibilities of the position. Related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work
- Experience working on Quality Systems, and complaint Management system
- Experience working with Agile, Salesforce and Trackwise
- Advanced level skill in MS Excel and other Microsoft office tools.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
- Ability to form and develop interpersonal, professional relationships and display socially and professionally appropriate behavior.
- Ability to work independently with minimal supervision and in cross functional group setting.
- Demonstrated initiative and problem-solving skills.
- Ability and aptitude to use various types of databases and other computer software.
- Strong organizational and project management skills.
- Ability to quickly gain knowledge, understanding or skills and is willing to learn.
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