The Service Provider shall perform independent oversight activities and shall not perform or assume responsibility for supplier manufacturing or product release decisions.

2.1 Supplier Oversight & Governance

- Act as an independent quality oversight body, separate from supplier operations
- Monitor supplier:
- Product testing execution
- Deviations, nonconformances, and CAPAs
- Quality system effectiveness

- Participate in governance forums and provide objective reporting directly to Company
- Maintain documented independence from supplier influence

2.2 Product Testing Oversight

- Verify supplier adherence to:
- Validated test methods
- Approved specifications

- Confirm:

- Test methods are approved by Company prior to implementation
- Equipment remains in validated state (IQ/OQ/PQ)
- Laboratory controls meet regulatory requirements

2.3 Data Integrity & Verification

- Perform independent verification of:
- Raw data vs reported results
- Test records and documentation

- Ensure compliance with ALCOA principles
- Provide input to Minimed to conduct Trend analysis, Anomaly detection

2.4 Batch Oversight (Post-Release)

- Conduct independent post-release review of batch documentation
- Review:
- Certificates of Analysis (COA)
- Supporting data sets

- Provide risk-based recommendations to Company regarding:

- Product acceptance
- Potential distribution risks

2.5 Escalation & Risk Management

- Identify and escalate to company risk conditions including:
- OOS/OOT results
- Data integrity concerns
- Repeated deviation trends





- Escalations shall be made directly to Company without supplier mediation
- Recommend containment actions including Shipment holds

2.6 Sampling & Statistical Oversight

- Verify supplier sampling plans align with: ISO 2859-1 / ANSI Z1.4 standards as applicable
- Evaluate effectiveness of: Normal / Tightened / Reduced inspection levels if utilized by supplier
- Provide independent recommendations regarding sampling adequacy

2.7 Performance Monitoring

- Develop and maintain oversight scorecards including: Lot acceptance rate, OOS/OOT trends, CAPA effectiveness, Data integrity metrics
- Identify: Process drift, Emerging risks
- Conduct reviews of performance monitoring and provide recommendations for increased oversight or revalidation

This position is located in the vibrant city of Reynosa, Mexico, offering a dynamic work environment and the opportunity to engage with a diverse and skilled workforce.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

📌 Independent Supplier Quality (Reynosa)
🏢 LanceSoft
📍 Reynosa