Engineer, QA II

Support and follow up the suppliers to ensure that quality relevant materials and services meet
specifications and Company requirements.
Keep approved suppliers in compliance and document the entire process to meet the requirements of
regulatory agencies and QMR03 Supplier Controls policy.
Coordinate with other areas of the Company to comply with the procedures and goals established in the
area.
Open, notify and track progress SCARs (supply corrective actions) to suppliers. Approve the corrective actions from the supplier and confirm with submitted evidence that committed activities were met
Notify “alerts” to suppliers based on trend analysis, supplier metrics (supplier performance) or defects found during manufacturing or complaints processes. Perform follow-up of supplier notice alert, when needed.
Track blocked, on hold and quarantine materials to determine a material disposition to comply with
the business goals or metrics. Define and execute material disposition of non-conforming materials.
Update and review the supplier metrics which show the quality performance of local and global
suppliers. Present monthly data to management.
Encourage suppliers to comply with periodic review and maintenance requirements for supplier
qualification such as “Quality Agreements (QTA)”, quality questionnaires (survey or self-assessment,
QQ), supplier audit, Supply chain maps, change notification, etc. Coordinate with the supplier the
completion and submission of QQ, QTA and material documentation.
Support and track the annual schedule of supplier audits (on site or quality questionnaire) to assure
that they are executed and completed on time. Present monthly status or supplier audit results to
management.
Provide corporate auditors with information needed about supplier performance, SCARs, CoC,
material specifications and receival verification process as part of preparation of an incoming audit.
Perform any assessment or action needed as a result of supplier audits.
Maintain ASL (Approved Supplier Lits in GTW) and S/4 system updated as the result of supplier
qualifications, change control actions, new material qualifications or projects activities.
Train contractors and consultants in the procedure of quality standards, requirements and GMPs
All other duties inherent to the position and those assigned by his/her immediate supervisor, including opening or closure of actions related to deviations, NC’s, CAPAS, DCC’s, CCs, AIAs, OMR presentations and internal audit responses.
EDUCATION:
Bachelor's degree in electrical, mechanical, electronic, electromechanical, industrial engineering, biotechnology, chemistry, computer science or related career or a combination of equivalent career experience in supplier quality rols.
English B1
EXPERIENCE:
1 year of experience in regulated industries. Expertise in supplier quality management is a plus.
SKILLS:
Knowledge on root cause determination tools, such as DMAIC or A3, among others.
Advanced knowledge of Office applications (Windows)
Ability to communicate written and oral ideas in a clear, concise and precise manner.
Critical thinking and continous improvement

Skills
Documentation

Experience
1+ yrs

Employment type
Full-time

Work arrangement
Hybrid