Supplier Quality Engineer 3 CR - Packaging
Post Date 13 hours ago
**Education** **/ Educación** **:**
Bachelor's Degree in Materials/Chemical/Industrial Engineering or similar Engineering professions.
It is a requirement to have technical knowledge in Packaging’ processes, such as thermoforming, plastic pouches, Tyvek pouches, etc. (Must).
**Experience** **/ Experiencia** **:**
5 or more years of experience in positions of similar responsibilities, decision making and trouble shooting.
At least 2 years of experience in packaging processes.
**Specialized Knowledge (Desirable)** **/ Conocimiento especializado (preferible)** **:**
ISO 13485 leader auditor (Desirable).
Quality System Regulation/EU MDR/EU IVDR (Desirable).
Negotiation course (Desirable).
Risk management (Desirable).
Validations and root cause analysis (required).
PPAP (Desirable).
Distribution testing for medical and in-vitro devices (required).
APQP process knowledge is a plus (Desirable).
**Languages** **** **required for the position (Desirable)** **/ Idiomas requeridos para el puesto (preferible)** **:**
Advanced English (100% Oral and written) (required)/Spanish (desirable).
**Computer tools and knowledge level required** **(Desirable)** **/ Herramientas informáticas y nivel de conocimiento requerido** **:**
Microsoft Office (required)
Project, Visio, Mini Tab (desirable)
Oracle, Agile (desirable)
**Qualifications** **/ Cualificaciones** **:**
Conflict management
Planning
Organized
Handling ambiguity
Decision quality
Trust and integrity
**Summary of Duties and Responsibilities** **/ Resumen de funciones yresponsabilidades** **:**
Execute all applicable activities
to comply with regulatory standards and meet the requirements stablished in the
Quality Management System around supplier’s quality management.
Conduct through technical reviews
on Packaging raw materials suppliers to understand their capability to make
parts.
Oversee, asses and monitor
suppliers making Packaging parts as it relates to manufacturing, process and
quality control practices, corrective action, continuous improvement, and
“First Article Inspection”.
Define and approve PPAP
requirement for all new and revised Packaging purchased parts (as applicable).
Follow up for their on-time completion.
Work along with the Packaging raw
material suppliers, to exceed the “fit, form and function” and reliability
requirements, while working internally with Research & Development and
Design Assurance.
Issue and follow up on Agile
Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers
providing Packaging components. Monitor timing of the workflows to comply with
key performance indicators stablished by Hologic, Inc.
Work collaboratively with
Packaging raw material suppliers on problem solving and root cause analysis to
avoid repeat failures. Apply (as applicable), metrology and statistical
measurement to problem analysis and resolution.
Work with Post Market
Surveillance and other applicable departments (Quality Engineering, MFG
Engineering, Research and Development, etc.) to address complaints linked to Packaging
raw material situations.
Resolve quality day to day issues
associated with Packaging raw material suppliers around the globe by addressing
non-conformities: call into containment and work along with the corresponding
departments to achieve disposition of the impacted Packaging raw material
(return to supplier, rework, sort, etc.). If applicable, collect and send back samples to suppliers if needed.
Work with Incoming Quality to
include suppliers in the “Skip Lot Program”, or remove suppliers out of it, if
applicable.
Maintain complete Packaging’s
supplier quality records as per the applicable procedure (e.g., supplier
performance key indicators, supplier’s quality certifications, etc.). Update
Packaging raw material suppliers’ files when required and check that the
information is accurate and complete, assuring that all applicable regulatory
standards are met.
Support audits as a subject
matter expert in Packaging. Travel might be required.
Update the ERP system with the
status of the approved suppliers for the different Packaging raw material
components.
As applicable, attend to
functional and departmental meetings and follow up on action items accordingly.
If needed, coordinate the change
in specifications and/or procedures when required through the corresponding
change order.
Train yourself in the respective
procedures in the training system, before executing the respective task.
Generate supplier performance
metrics to be used in decision making. Provide the necessary reports to the
Staff.
Coordinate Periodic Quality
Review meetings with Packaging raw material suppliers that require it, as well
as follow up on the activities agreed upon in these meetings to ensure that
they are carried out.
Coordinate and execute activities
related to the implementation of new Packaging raw material suppliers as a
result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the
suppliers comply with the requirements stipulated in the quality system before
the closure of the projects.
Qualification of new suppliers
and/or new parts/components of an already approved supplier.
Perform other duties as required
by his/her manager.
