DePuy Synthes, Palm Beach Gardens, FL
The Orthopedic Company of Johnson and Johnson.
Supplier Quality Engineer 4/20-Current
- Supplier Quality tram member for QMS updates to European Regulations (MDR)
- Supplier Quality team member for the introduction of variant product/processes
- Manage supplier validation and qualification activities for legacy and new product introduction, as well as
- Supplier Change management (SCR)
- Conduct supplier related Nonconformance investigations
- Member of supplier consolidation initiative
Mercury Medical, Clearwater, FL
A manufacturer of quality Airway Management Devices also specializing in anesthesia, emergency and critical care products.
Quality Engineer 10/17- 4/20
- Manage and conduct all investigations for the Complaint and Nonconformance System (CAPA system).
- Maintains company calibration equipment/records and manages all PM schedules for said equipment.
- Performs new and recurring supplier evaluations as part of the effort to ensure quality materials are used to make a quality product.
- Responsible/Owner of SOPs related to Calibration, CAPA, Complaints, NCR, Recalls, and Vigilance Reporting.
- Quality team member for the launch, implementation, and validation of new ERP system.
- Maintain and update Declaration of Conformity, GUDID, and Canadian Product licenses as new and updated product is being developed.
- Participated in MDSAP preparations and audit.
ALCON, Duluth, GA
1/14 – 7/17A subsidiary of Novartis, Alcon is a $2.3 billion high-volume manufacture of contact lenses. Manufacturing Engineer (Light Stream 3 – LS3) 10/14-7/17
- LS3 launch training team member -(3 month) training in process strategies, Grosswallstadt, Germany.
- Hand-picked member of launch team for Dailies Total1 product line.
- Conduct nonconformance investigations -recognized expert for mixed product and debris issues.
- Coordinate with cross-functional teams to ensure timely review, approval, and closure of records.
- Developed Corrective Action & Preventative Actions (CAPA) for non-conforming products or process.
- Lead and participate in cost reduction and process improvement projects (Lean Manufacturing).
- Team representative and “voice of the team” in Kaizen events.
- Member of only team that meet “Green metrics” performance, recognized as top-performer for team.
- Write and execute protocols and engineering studies as part of non-conformance investigations.
- Create reports and maintain metrics for the CAPA team to track and trend recurrences and cycle times.
- Lead and participate in escalations and dispositioning of product decisions.
Quality Engineer (Light Stream 1 –LS1) 1/14-10/14
- Internal audits of manufacturing equipment & personnel to comply with GMP & FDA standards.
- Analyze effectiveness of current SOPs and lead redraft process.
- Failure prevention lead when new or unknown non-conforming products or process arise.
- Perform effectiveness checks and gap assessments for prevention of found product failures.
- Support functions for continuous process improvement.
- Determine and report on scope and product impact when non-conformances are found.
- Review batch records for accuracy, GDP, and completeness.
- Peer training effectiveness which led to LS3 promotion.