This section focuses on the main purpose of the job in one to four sentences.
Independently produces and completes Supplier Quality Engineering Documents, and supports supplier quality assurance key activities where needed.
Primary Supplier Quality Engineering activities
- Qualification of Parts (including spare parts and raw materials e.g. API for Pharmaceuticals, components for devices) and services, identification of supplier processes for Critical to Quality (CtQ), and supplier process control plans to ensure part quality; ensures that the supplied parts/materials meet specifications, and the control limits/tolerances for CtQ parameters are met.
- Qualifies and sustains sub-processes of suppliers, including critical process validations for critical supplier processes impacting part quality to medical device or pharmaceutical process validation standards
- Ensures that the components/products at the supplier (including spare parts, raw materials and services) are released according agreed specification and quality requirements including SQ audits.
- Executes SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed.
Supports the following supplier quality assurance activities where needed:
- Setting quality management system requirements to suppliers
- Managing and overseeing approved supplier list and related supplier master files
- Ensuring adherence to audit schedule and performance of audits only by qualified auditors
- Tracking and trending supplier quality metrics
- Coordinating purchasing controls CAPA activities, ensure timely and effective closure
- Developing processes and systems in alignment with Baxter Quality Management system
- Coordinating and facilitating integration for acquired facilities and divestiture of closed facilities into the Baxter Supplier Quality System.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- Executes Primary supplier quality engineering responsibilities, and supports assurance responsibilities where called upon
- 1. Sets part/material quality requirements to suppliers independently with minimal supervision and in partnership with cross-functional team members; this includes translation and flow down of Critical to Quality features from design to manufacturing.
- 2. Independently contributes to supplier qualification activities (e.g., Baxter Top Projects, outsourcing to contract manufacturers); independently accountable for documenting supplier technical capabilities as part of supplier selection processes, and ensuring supplier quality capability (CpK, including ding spare parts); accountable for purchased part quality (including spare parts) through the life cycle
- 3. Independently accountable and responsible for material qualification, including part quality/control plan, advanced part quality planning/purchased part approval processes through NPI and design changes
- 4. Accountable and responsible for establishing requirements for Material Acceptance where applicable, with minimal supervision or instruction, including documenting Receiving Inspection Plans where applicable.
5. Accountable for and conducts supplier monitoring, including Supplier Quality Notifications (QN’s), Supplier Corrective Action Requests (SCARs) as assigned, conducting SCAR timeliness and effectiveness reviews, and trending for corrective/preventive actions, Lead and/or manage assigned BG or Global SQA initiatives in partnership with critical stakeholders.
- 6. Conducts supplier qualification/re-qualification, including audits and ensure execution of the contractual definition and agreement; Responsible for timely completion of supplier audits, assessments as assigned on product and process specifications with the supplier (e.g. PQA / MQS) in partnership with Operations & Procurement, and/or 3rd parties (e.g., Rx-360, MedAccred)
- 7. Accountable for executing and documenting supplier quality reviews, and supplier performance management; deploys and follows-up on the Supplier Quality Related KPI’s towards the supplier and SQE’s
- 8. Accountable for conducting targeted supplier quality process improvement (SPI); Accountable and responsible for coordinating supplier –initiated changes impacting product quality
- 9. Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,
- Supports the following SQ Assurance activities where needed:
- Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets
- Performs qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence ( Supplier Master File)
- Conduct and oversee supplier audits- qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics
- Improve/develop quality systems at selected suppliers for QMS and compliance improvement
- Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods
- Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements
- Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure
- Develop and/or deliver training to internal teams and suppliers.
- Executes SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs/NCR where needed.
- Coordinate duties and responsibilities of acquisition or divestiture with the facility, develop/execute/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the GSQ TrackWise database.
- Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.