SUMMARY:

15 years of Quality engineering experience in the Medical and Pharmaceutical industries. Involved with product development, manufacturing, validation and qualification, Risk Analysis, Management and Mitigation activities (CAPA’s), FMEA activities, Design of Experiments, Protocol authorship for manufacturing and validation plans, Testing methods and all aspects of manufacturing process and procedure development for components and assemblies. My background includes a high level of expertise in the disciplines of new and upgrade product design, Quality controls, test engineering and experiments, ISO 9000, 9001 and 9002, Lean Manufacturing, cGMP, Project and Proposal management, Statistical Process Controls for data defined problem resolution.

PROFESSIONAL WORK HISTORY:

Confidential, Highland Heights, OH

Quality Engineer

Responsibilities:

• SME for the evaluation and disposition of day to day issues and CAPA’s for software, process, vendor and production issues.
• This position has required the ability to both manage allocated resources and as well as functioning as an “independent contributor” for validation, verification and life cycle maintenance of extremely complex Imaging and diagnostic based software controlled systems.

Confidential, Lake Forest, Illinois

Supplier Quality Engineer

Responsibilities:

• Critically involved in participating and approving Supplier quality audit reports for medical devices and pharmaceutical drug products per federal and international regulations and international standards.
• Additional responsibilities have included approving and following - up CAPA plans and coordinating pivotal information between Company sites and suppliers using Trackwise and Sharepoint.
• The role has also involved on a tracking aspects of remediation projects per regulatory commitment.
• Proactively facilitating communication through conference calls with suppliers globally and management, on a daily basis.

Confidential, Madison, WI

Quality Engineer

Responsibilities:

• Key attributes of the role included: Writing, implementing and proactively engaging with cross functional groups in CAPA management for planned and unplanned manufacturing and laboratory deviations in oral solid dosage drug manufacturing.
• Critically involved in reviewing and compiling analytical data and risk assessments for client specific projects.
• Actively involved with cross-functional teams such as engineering and manufacturing in executing validation protocols.
• Key technical reviewer of DOE, Validation protocols, and Method Transfers.
• Additional responsibilities included technical lead in instrument IQ/OQ/PM and performing analytical tests on oral solid dosage on drug product, raw material and excipients using various instruments governed by USP, JP, EP, Industry standard methods and client specific methods. Involved in quality improvement projects

Confidential, Hudson, WI

Sr. Quality Engineer

Responsibilities:

• Responsibilities include execution of all Design Controls to including supplier management, incoming inspection activities, IQ/OQ/PQ Validations, Input-Output Verification, DFMEA, UFMEA, and PFMEA Activities, Process Flow Diagrams, Quality Plans, Design Changes, Test Method Validations, Design of Experiments and Gage R & R Studies associated with the Development of Class II and III Ocular Implant System and disposable Refill Nedle.
• Conducted supplier audits with enfaces on design for manufacturability and improving supplier performance.
• Evaluated suppliers to determine suitability for the project and ability to deliver quality product that will mean stringent timelines.
• Worked hand in hand with suppliers to develop and improve their validation efforts and ability to conduct IQ/OQ/PQ’s that would meet stringent pharmaceutical regulatory requirements.
• Developed incoming inspections along with Purchase Component Quality Agreements (PCQA’s) to insure suppliers were providing the products that had been agreed upon and insure defects were quarantined.
• Worked directly with the suppliers to evaluate defect and determine root cause and corrective actions at the suppliers’ location.
• Reviewed Capability Study data to determine normality and insure compliance to internal standards.

Confidential, Ann Arbor, MI

Quality Engineer

Responsibilities:

• Provided CAPA initiation and Root Cause investigations in conjunction with Confidential remediation.

Confidential, Chaska, MN

Senior Quality Engineer

Responsibilities:

• Perform gap analysis of the quality system. Develop Master
• Validation Plan and revise procedures to remediate the observations noted in preparation for revalidation activity that would close the gaps and increase the confidence level going forward.

Confidential, Minneapolis, MN

Regulatory Affairs/Quality Engineer

Responsibilities:

• Supporting new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
• Responsible to generate all the required documentation in support of manufacturing products and processes.
• Engineering protocols, FMECAs, reports, manufacturing instructions and procedures.
• Responsible to develop and improve manufacturing methods, systems and processes to produce a high quality product at optimal cost.
• Continually improving manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
• Responsible to ensures compliance with GMP’s and internal protocol along with using appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
• Developing plans to evaluate process repeatability and stability through equipment qualification and process validation along with applying six sigma methodologies. Interfacing with suppliers, engineers, architects and/or contractors effectively

Confidential, Maple Grove, MN

Quality Engineer

Responsibilities:

• Assisted in the removal of the Confidential Letter and Remediation of Legacy systems.
• Improve quality performance of processes through completion of Corrective and Preventive actions (CAPAs) and eliminating non-conforming events.
• Process Validations, Qualifications, Design Verification and scaling up of new products.
• Implement Lean Manufacturing principles.
• Identify and implement cost reduction and process improvements.
• Implement statistical In-process
• Monitoring for critical characteristics.
• Develop protocols and standards for production.