MAIN PURPOSE OF ROLE
Leads in establishment and maintenance of supplier quality engineering methodologies, systems and practices, which meet company and regulatory requirements. Provides engineering support for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.
**MAIN RESPONSIBILITIES**:
- Leads in maintenance and improvement Abbott supplier quality program policies, procedures and forms.
- May supervise other Supplier Quality Technicians and or receiving inspection personnel.
- 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 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 judgement to reduce the need for inspection in accordance to program policies.
- Works with Manufacturing engineering to assess and address purchased product issues.
- Participate in supporting Supplier Assurance program requirements (e.g., represent the Supplier Assurance function as a Core Team Member.).
Education
- Bachelor degree or Technical Field (STEM careers).
Experience/Background
- 6 Months Quality Inspection experience or as equivalent an Internship in Receiving Inspectionor Supplier Quality area (as part of Abbott's Technical DegreeHigh School Program).
- Knowledge 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, and ISO 13485.
- Technical writing Knowledge.
- Ability to travel approximately 10-40%, including internationally
- Advance Commands of English / Required
- Prior medical device experience preferred.
- ASQ CQE, CQA or CSQP certification
- Experience with SAP supply chain modules or similar ERP system.
- Basics statistics knowledge
