Supplier Quality Engineer - Queretaro site
**About Abbott**
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.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
- Career development with an international company where you can grow the career you dream 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.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
Supplier Quality Engineer is responsible for activities related to supplier selection and evaluation, material qualification, supplier performance, receiving inspection and work very close with Supply Chain team. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements. As required, supervises the activities, manpower and resources within the functional area to ensure support is provided to meet the department and company goals.
**What You'll Do**
- Assesses potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. Evaluates, monitor, and approve new and existing external suppliers based in their qualifications and performance, acts as a spokesperson to external suppliers.
- Generates test protocols, monitors testing, issues material qualification test reports and approves components for use.
- Assists in generating component specifications, generates and maintains incoming inspection procedures and provides input from component quality, inspectability and manufacturability perspective. Trains inspectors to these procedures as required
- Leads in maintenance and improvement Abbott supplier quality program policies, procedures, and forms.
- May supervise other Supplier Quality Technicians and or receiving inspection personnel.
- May provide mentoring for team personnel.
- Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques,
Gage R&R studies and inspection procedures.
- Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
- Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier
corrective action requests and technical discussions.
- Reviews and approves all supplied product drawings and component quality plans.
- Works with Manufacturing engineering and Supply Chain to assess and address purchased product issues.
- Evaluates and develops Supplied Data Agreement partnerships with suppliers.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company
policies, operating procedures, processes, and task assignments. Maintains positive and cooperative
communications and collaboration with all levels of employees, customers, contractors, and vendors.
**Required Qualifications**
- ** Education**. Bachelor degree or Technical Field. (STEM careers). Major/Field of Study : Engineering, Science or equivalent field of study
**Experience**
- 3+ years experience, with 2+ years in Quality Engineering roles.
- Preferrable in supplier quality engineering roles
- Prior medical device experience.
- Demonstrated use of Quality tools/methodologies, such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
- Knowledge of FDA, GMP, QSR CFR 21 Part 820 and ISO 13485.
- Experience implementing various product and process improvement methodoligies.
- Technical writing Experience.
- Quality Auditor experience for ISO 13485 or 9001.
- Ability to travel approximately 10-40%, including internationally.
- Intermediate statistics knowledge
- Language Proficiency : Advance Commands of English / Required
**Preferred Qualifications & Education**:
- Demonstrated supervisory experience.
- ASQ CQE, CQA or CSQP certification preferred.
- Quality Auditor training for ISO 13485 or 9001.
- Previous Supplier Quality engineering or Receiving Inspection experience.
- Experience with SAP supply chain modules or similar ERP system.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.