Sr Quality Supply Engineer

Sr Quality Supply Engineer
Empresa:

Abbott Laboratories



Área:

Otros

Sr Quality Supply Engineer

Detalles de la oferta

JOB DESCRIPTION: Supplier Quality Engineer is responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements. Position will be responsible of the personnel facilitation, training and development.

MAIN RESPONSIBILITIES

- Contributes to the development, maintenance and improvement of Abbott supplier development quality program policies, procedures and forms.
- May provide mentoring for team personnel.
- Supervises personnel and supports the work, projects and tasks associated with quality systems for the different business units.
- Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
- Reviews and approves all supplied product drawings and component quality plans.
- Manages development of supplied product inspection procedures and first article requirements.
- Provides engineering guidance to Abbott 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.
- Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
- Contributes and participates in supplier performance reviews.
- Evaluates and develops Supplied Data Agreement partnerships with suppliers.
- Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
- Works with manufacturing engineering to assess and address purchased product issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Design and conduct experiments for process optimization and/or improvement.
- Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member).
- 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.

QUALIFICATIONS

- Bachelor degree in Engineering or Technical Field.
- 5+ years experience, with preferably 3+ years in quality engineering roles.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- 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, such as Lean Manufacturing.
- Technical writing Experience.
- Quality Auditor training for ISO 13485 or 9001.
- Ability to travel approximately 10-40%, including internationally.
- Fully Billingual. (English / Spanish) required.
- Demonstrated supervisory experience.
- ASQ CQE, CQA or CSQP certification preferred.
- Previous Supplier Quality engineering or Receiving Inspection experience.
- Experience with SAP.

JOB FAMILY:
Engineering

DIVISION:
CAHF Cardiac Arrhythmias & Heart Failure

LOCATION:
Costa Rica Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2

ADDITIONAL LOCATIONS:

WORK SHIFT:
Cr09Sal (Costa Rica)

TRAVEL:
No

MEDICAL SURVEILLANCE:
Yes

SIGNIFICANT WORK ACTIVITIES:
Work in a clean room environment


Fuente: Bebee2


Área:

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