Quality Control Specialist I
1 week ago
**Responsibilities**:
- Lead and drive internal and/or supplier non-conformances to ensure timely disposition for closure of QNs
- Identify and drive continuous Product Quality improvement of internal manufacturing processes for existing products.
- Perform monitoring and analysis on creeping issues on reported Customer Returned Instrument history and identify continuous Product Quality improvement opportunities.
- Identify and establish in-process/ outgoing Product QC inspection criteria and provide training to QC Technicians.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
- Maintain and ensure Products CDF are timely updated for Product Safety periodic assessment by certification house.
- Participate and review Site Process Validation activities to ensure Quality control adequacy.
- Generate and analyze weekly, monthly Product Quality performance reports for Management review.
Qualifications:
- Bachelor’s Degree in Mechanical or relevant engineering.
- Minimum 1 years of manufacturing quality control in regulated environment is preferred.
- Experience in Process validation activities as Quality function.
- Experience with ERP systems a plus, SAP preferred.
- Knowledge of MDSAP and/or ISO13485 requirements. Preferable lead auditor certified.
- Possesses excellent problem-solving, interpersonal, communication and leadership skills.
- Must be self-motivated, result oriented with mínimal supervision.
- Certified Quality Engineer and/or Certified Reliability Engineer will be preferred.
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