Quality Engineer Resume Irvine, CA - Hire IT People

SUMMARY:

To utilize my skills and experience gained throughout my career to obtain a position within the Medical Device industry.

EMPLOYMENT EXPERIENCE:

Confidential, Irvine, CA

Quality Engineer

Responsibilities:

perform Gap Analysis to address Invalid and Boundary testing for Terumo's manufacturing systems and the associated application software's.
Create Change Analysis Forms, update User Requirement Specifications (URS), Functional Requirement Specifications (FRS), developed test cases and executed protocols for IQ/OQ/PQ and documented Qualification Reports and Validation Summary Reports.

Confidential, Minneapolis, MN

Quality Engineer

Responsibilities:

Responsible for activities related to investigating medical device complaints and maintaining audit ready files that meet the requirements of FDA CFR Title 21 part 820.
Activities include but not limited to: analysis of returned complaint products, reviewing risk management files, CAPAs, surgical techniques and utilizing sales data for calculation of occurrence rates.

Confidential, Hudson, NH

Principal Quality Engineer

Responsibilities:

Confidential, Batesville, IN

Regulatory/Quality Assurance Engineer

Responsibilities:

Responsible for the review of a large volume of complaints completed by the engineering remediation team.
Review for content, failure mode, risk assessment, CAPA accuracy of root cause, MDR review recommend and require revisions based on review.
Write the executive summary based on engineering remediation review.
Sign as final approval of executive summary.
Sign as final approval for the closure of the complaints.
Recommendation of CAPA as required.

Confidential, Irvine, CA

Validation Engineer

Responsibilities:

Write IQ/OQ protocols, traceability matrices, and summary reports for a new product line to qualify equipment to FDA 21CFR820 for a facility that manufactures form - fill-seal style IV bags.
Equipment includes, overwrap machines, particulate matter inspection stations, case erectors and sealers, directions-for-use feeders, case weighers and case printers.

Confidential, Pleasanton, CA

QA Representative

Responsibilities:

FDA registration and FDB certification for Pleasanton site and CE marking for UK site.
Implement Internal audit system and getting ISO13485 Certifications for Pleasanton site.
510K submission support for two products on Regulatory & QSR Compliance.
Training programs for Pleasanton and UK sites, ISO,GMP,GCP, QSR, GLP, ICH and OSHA Safety.

Confidential, Maple Grove, MN

Quality Engineer

Responsibilities:

Author Validation deliverables such as URS, FS, IQP, OQP and PQP. Execute Validation protocols such as IQP, OQP and PQP.
Develop Requirement Traceability Matrix. Perform Compliance Gap Analysis.
Conduct Root Cause Analysis.
Place documentation under Change Control. Quality Approver - Review all documentation.
Work cross-functionally with Quality, Manufacturing, and Process Development to develop and resolve quality issues arising out of validations.
Work with Calibration Department for the calibration certification of the equipment.
Work with external vendor equipment. Work with OEMs and their customers.

Confidential, Oakdale, MN

Quality Specialist

Responsibilities:

Perform mechanical assembly, testing, troubleshooting and inspecting of laser optics and its related products in a clean room environment to cGMP, FDA 21 CFR 820 Quality Systems Regulations and ISO 9001 requirements.
Participate in product verification and process validation activities (IQ, OQ, PQ).
Create standard operating and testing procedures for laser optics units for laser scanner X-rays dry process and subsystems beam alignment resulted in accuracy from 76% to about 95%.