Kathleen A. Lavender

Phone: 954-***-****

acqyf8@r.postjobfree.com or acqyf8@r.postjobfree.com

Profile:

Technical professional with a proven track record of strategic vision, quick delivery, and demonstrated ability to inspire/mentor quality assurance teams to implement the latest QA programs for maintaining industry regulated quality standards. Extensive experience in customer relationship management, change management, ISO 9001, ISO 13485, ISO 15378, ISO 14791, CRF 210, 211, 820, MDD and TS 16949, New Product/ Process Validation Activities, rapid problem solving, process creation, technical documentation, supplier development and technical training across all functional levels.

Management level experience using Statistical Tools and DMAIC problem solving. Professionally trained in Risk Management and Lean Manufacturing.

Professional experience:

Quality Systems Manager

2/2015 – present International Medical industries (Injection Molding) Pompano Beach, Florida

Design and implement ISO 9001, ISO 13485 and CFR 820 compliant Quality Management Systems. Track and trend plant quality matrices, such as scrap, complaints, CAPAs, OTD, and continuous improvements.

Design and manage product and process validations, cleanroom qualifications, equipment qualifications, facility expansion projects and other projects as required.

Responsible for conducting onsite supplier audits, managing the supplier development programs along with the supplier corrective action database.

Review technical protocols, data and reports for validations, engineering specifications, and production readiness transitions. Perform quality review of documents including nonclinical protocols, reports, batch records, and other manufacturing documents from internal departments and external vendors.

Quality and Regulatory Manager

2/2014 -2/2015 Interplex Sunbelt, (Injection Molding & Precision Metal Stamping) Tamarac, Florida

Responsible for plant level quality systems and product quality with adherence to 21 CFR Part 820 regulations, ISO 13485, ISO 9001 and TS 16949. Duties include the development and implementation of validation program to ensure that all processes, cleaning activities, and analytical methods meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Provide leadership for Quality Management Systems to ensure systems are effective and compliant with all internal and external customer expectations, corporate requirements, and industry specific standards, regulatory and statutory requirements.

Sr. Quality Systems and Regulatory Engineer

4/2013 – 3/2014 Corning Inc., Corning, NY (Glass Manufacturing / Contract work)

Areas of focus in Primary Packaging for Medical Devices.

Responsible for system implementation and maintenance of a plant level quality system to comply with ISO 15378.

Responsible for overseeing departmental duties of Corrective and Preventive Action (CAPA), MRB, change management, receiving inspection, in-process and final inspection, supplier quality, and internal quality audits. Shared primary responsibilities to re-engineer the process validation program to model the requirements of the International Medical Device Regulators Forum (IMDRF).

Quality Manager

11/2007 – 6/2013 K&W Medical Specialties (a division of MedPlast/ Injection Molding) Westfield, PA

• Serve as Quality Management Representative and reported directly to the President.

• Design and implement ISO 9001, ISO 13485 and CFR 820 compliant Quality Management Systems

• Track and trend plant quality matrices, such as scrap, complaints, CAPAs, OTD, material variances, MRB and cost of quality for lean business practices and continuous improvements.

• Lead product defect/reject reduction projects within internal and/or customer facilities.

• Design and manage product and process validations, shipping & packaging validations, cleanroom qualifications, compressed air, equipment qualifications, facility expansion projects and other projects as required.

• Host customer and regulatory audits.

• Manage supplier audits, supplier corrective actions and supplier development programs.

• Direct oversight of all plant QA personnel (33 direct reports)

• Co-Chair corporate quality team objectives to harmonize plant quality documentation between five plant locations.

Sr. Manufacturing Engineer/ Quality Engineer

3/2002 – 11/2007 Synthes USA. (Surgical Implants/ Precision Machining) Horseheads, NY

• Manufacturing/ Quality Engineer for a Medical products manufacturer specializing in surgical implants.

• Provided input into product design and represented company to client engineering and manufacturing support teams

• Recommended and developed manufacturing processes for new projects, farm-in projects and process improvements.

• Recommended and developed inspection and sampling techniques, quality plans, process control and procedures that would ensure production of finished products, which meet specifications.

* Analysis of internal / external failures, customer complaints, initiate corrective actions and provided written and verbal reports of quality studies and analysis.

* Provided technical support to machining operations in solving process problems and manufacturing issues.

* Trained and provided technical support to quality team personnel during new product launches for anatomically correct surgical implants.

Technical Services Manager

8/1997 - 3/2002 HN Automotive Inc. (Precision Machining and Assembly) Wellsboro, PA

Joined the company as the Quality Systems Coordinator (1997) and was promoted to technical services manager (1998) Provide daily supervision/management (38 direct reports) and assigned priorities for both the Quality and Engineering Departments for a precision machining operation.

• Planned and coordinated details of highly complex, large scale engineering and quality projects for new products while promoting safety and continuous improvement

• Assisted in the design and arranged for the procurement, of manufacturing equipment, machine tools, and inspection and test equipment, tools, gauges, fixtures etc.

• Establish and maintain manufacturing process specifications, recommend improvements and additions of new equipment for manufacturing processes. Identify and recommend cost reductions and improvements to existing processes.

• Established goals that were consistent with quality cost objectives, particularly in the areas of manufacturing losses and providing products which fulfill the customer requirements at a reasonable cost.

• Managed all aspects of the ISO/QS 9000 Quality program including Supplier Development and Supplier Assessment - from implementation through the successful completion of several surveillance audits.

• Maintained accurate and up to date records, tooling, master files, document files, specifications, prints, final assembly/ configuration management records; and analysis to indicate quality trends and product traceability.

• Coordinate team efforts to reduce our outgoing PPM levels and improve our internal OEE.

Quality Manager (12 direct reports)

9/1995 – 8/1997 PGM Rochester, NY

• Recommended, planned and established goals to achieve quality objectives utilizing T.Q.M and ISO 9000 Standards.

• Implementation of quality awareness programs, activities and training in a contract machining environment.

• Provided daily assistance to production operations in solving technical problems related to inspection techniques, machining and tool wear.

• Designed and implemented auditing systems to control the manufacturing processes in a stable and consistent manner to provide for continuous improvement both internal

Quality Supervisor (5 direct reports)

7/1992 - 8/1995 C.J. Winter Rochester, NY

Direct responsibility for inspection and metrology department

Drafter/ Engineering Technician

5/1990 - 7/1992 BioSurge Inc Rochester, NY

Assisted both Engineering and Quality in new product testing for single use Medical Devices.

Design/ Drafter

Engineering Technician

8/1981 - 5/1990 Eastman Kodak. Rochester, NY

* Successful completion of the Engineering Training Program provided in conjunction with Rochester Institute of Technology.

Education

Rochester Institute of Technology Rochester, NY

BSMET: Mechanical Engineering Technology

Professional memberships

ASQ, Society for Woman Engineers, National Association for Female Executives

References

Provided upon request

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