Sr. Quality Assurance Engineer Resume Ave Maria, FL - Hire IT People

PROFESSIONAL EXPERIENCE

Sr. Quality Assurance Engineer

Confidential, Ave Maria, FL

Responsibilities:

Ensure Quality Systems is compliant with 21 CFR 820 and ISO - 13485 for a Class I, II and III orthopedic medical devices (knee and hip) implantable and non-implantable devices.
Nonconformances: Investigate nonconformances for incoming and processes for orthopedic knee and hip product lines to determine root cause.
Risk Management: Develop risk management files including creating pFMEAs as per updated procedures (remedial actions).
Cost improvement: Reduce inspection process for Select Verification Inspection (SVIs) for raw material and processes.

Sr. Quality Engineer

Confidential

Responsibilities:

Ensure Quality Systems is compliant with 21 CFR 820, 21 CFR 1271, and ISO-13485 for a Class I, II and III spine medical devices, surgical instruments (non-implantable), and tissue implantable.
Complaint handling: Investigated post market implantable and non-implantable complaints to determine root cause and corrective actions. Accessed risk as per ISO 14971 and procedures to determine appropriate corrective actions if needed and/or identify and updates to pFMEAs, dFMEAs, and aFMEAs.
Documentation: Develop and improve quality system documentation as it relates to complaint handling and risk assessment.
Data trending: Attended data trending meetings and provided data trending data.

Sr. Quality Engineer

Confidential, Frederick, CO

Responsibilities:

Ensured Quality Systems is compliant with 21 CFR 820, ISO-9001, ISO-13485, and IEC-60601 for Class I & II electromechanical medical devices for contract manufacturing (design transfer to manufacturing process).
Audits: Led audits for the quality systems internal and external regulatory bodies including FDA, BSI, TUV, and CSA.
Complaint handling: Managed and approved complaint investigations.
Nonconformances: Approved nonconformances dispositions. Lead Material Review Board (MRB) meetings to determine root cause and worked with suppliers to determine corrective actions. Data trended manufacturing yields for reporting to management review board.
CAPAs: Opened, performed failure investigations, root cause analysis and implement corrective and preventive actions. Owned and assisted owners in the CAPA process. Reduced CAPAs opened aging by 70%. Data trended for Management Reviews.
Training: Trained quality engineers on the CAPA system and Complaint Handling including effective problem statements, investigation techniques (root cause), corrective, correction, preventive actions, and timely closing out with effective monitoring.
Validations: Assisted with process and software validations/verifications.
Risk management: Created and updated pFMEAs as per ISO 14971.
Documentations: Created and approved quality plans, manufacturing procedures, inspection plans, and specifications as need to insure compliance to ISO standards.
UDI Implementation: Overseen UDI implementation for customers and provided recommendations as per regulations and classifications.

Sr. Quality Engineer

Confidential

Responsibilities:

Ensure Quality Systems is compliant with 21CFR 820, Parts 4, 210 & 211, and ISO-13485 for a Class II Medical Device for combination product (surgical sutures) at Confidential & Confidential ).
CAPAs: Performed failure investigations, root cause analysis and implement corrective and preventive actions. Owned and assisted owners in the CAPA process.
Complaints: Performed complaint investigations including any that pertained to international sister companies such as Japan, China, and Mexico.
Risk Management: Worked with sister companies national and internationally risk management assessments and changes to dFMEAs and pFMEAs.
Audits: Supported and assist in quality audit including internal, process layer, Gemba walks, FDA, and BSI. Ensure site was audit ready.
Document/DHF: Assisted in design changes including approvals for new product development, engineer change orders, FMEAs, and batch history records (BHRs).
Validations: Developed validations for test methods including creating the protocol, overseeing testing, and final completion report.
Sampling plans: Created statistical inspection sampling plans including reviewing and approving utilizing Minitab, ANSI/ASQ Z1.4, and Zero Acceptance Number Sampling Plans. Sampling plans were generated for test method validation, non-conformance, retainage samples, and CAPA verification.
KPI and IPT Meetings: Attended KPI and IPT meetings for reporting status of critical quality operations to management, including non-conformances, WIP, and any batch holds including international holds. Supported and approved hold releases.

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Sr. Quality Assurance Engineer Resume

Ave Maria, FL

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