Jeffery Mark Shields Email & Phone Number

Florida, United States

Minneapolis, Mn, Us

Led cross-functional teams in Root Cause Analysis of complex investigations. Ensured deliverables were met per project timelines. Facilitated product and process investigations from issue Identification, Investigation, Action and Effectiveness phases include Effectiveness monitoring activities. Documented tracking and progress of phases utilizing Trackwise software. Also, incorporated Six Sigma Principles to drive data analysis and decision making along with Root Cause Analysis, Critical Thinking, Technical Writing training and skills.

Montmorency, Île-De-France, Fr

Created/Updated QMS Documentation for compliance to 21CFR 820 and ISO13485:2016 requirements for Medial Device Company manufacturing Neurovascular interventional devices . Also, wrote Protocols and Reports for Validation activities. Researched and selected Quality assurance inspection equipment for incoming receiving and manufacturing line inspection.

Responsible for all Aspects of Quality and Compliance for Medical Device Contract Manufacturer. Responsible for internal and supplier validations, supplier performance tracking, internal and external quality metrics, customer complaints, MRB and CAPA monitoring, investigation to resolution. Company Quality Representative in FDA and ISO inspections/audits. Authored responses and corrective actions for FDA/ISO 483/audit findings. Managed and participated in internal and supplier audits as part of supplier evaluation and acceptance. Executed capability studies and Gauge R & Rs on internal processes. Conducted PPAP activities per customer requirements to ensure we met all specifications and requirements for new product release including capability studies and quality plans by product.

Wrote Protocols for Special Processes. Created FMEAs and Control plans and Gage R&Rs. Wrote SOPS and Work Instructions and Modified Documentation to Improve ISO13485 and 21CFR 820 compliance.

Naples, Florida, Us

Managed a team of supplier validation engineers and technicians responsible for working with suppliers to achieve validated process to meet FDA standards for all orthopedic medical devices. Responsible for Supplier change request process for supplier process change activities. Ensured process was documented and prioritized activities. Communicated with internal stakeholders of change requests activities schedules and timelines for activities of suppliers. Review and assist in TMVs. Performed onsite audits of suppliers QMS to ensure compliance to ISO13485 and ISO9001. Provided summary reports of audits and followed up with Supplier responses to closure of audit findings Created and managed the Master Validation Plan and validation strategies. Managed and co-generated validation protocols with team members, including IQ, OQ and PQ documentation for manufacturing processes and equipment for Domestic and European Suppliers to ensure compliance with FDA compliance.

Kalamazoo, Mi, Us

Perform all quality functions associated with supporting Orthopedic Robotics Medical Device manufacturing operations. Responsible for validations for all medical device processes and equipment, responsible for CAPA and MRB investigation reports and investigations of customer complaints, writing validation reports, protocols, FMEAs, authoring relevant procedures and creating DMRs and DHFs files.

Naples, Florida, Us

Perform all tasks and responsibilities associated with validation functions. Responsible for validations for all medical device processes and equipment. Developed validation strategies and projects involving multiple departments and validation teams including supplier validations and development. Performed QMS supplier audits to ensure compliance to ISO13485 and or ISO9001 of all aspects of quality and manufacturing activities

Quality engineer-Responsible for generation of sampling plans and procedures per ANSI standards for incoming receiving and inspection of raw materials, writing CAPA investigation reports and root cause investigation of customer complaints. Reviewed and approved validation protocols and reports for packaging lines and equipment.

Marlborough, Ma, Us

Responsible for new Product development and Validation of products for medical devices. Other responsibilities include the writing of validation report, protocols, FMEAs, and procedures for compliance. Supported extrusion operations for guidewire catheter production and development.Supported manufacturing improvements and floor support. Analyzed processes, product, and material and equipment specifications relative to performance requirements and insured alignment. Drive the troubleshooting effort for any process issues in area. Lead value improvement projects. Continually drove improvements in process design and operational performance.

Qingdao, Shandong, Cn

Responsible for thermoforming process and tooling during refrigerator manufacturing plant startup. Also set up incoming inspection lab and performed capability studies on refrigerator components. Used Six Sigma tools to improve efficiency of operations plant wide. Also acted as liaison for all plastics component purchased parts

Miami Lakes, Fl, Us

Performed validations for new product development in extrusion area for medical catheter tubing manufacturing. Responsibilities included implementing process enhancements to improve the extrusion process capability of various extrusion lines. Carried out complex assignments requiring the development of new and improved techniques and procedures to achieve departmental goals for manufacturing and compliance.

New York, Ny, Us

Window coverings ManufacturerManager of Development and EngineeringResponsible for project management of all new and existing product line improvements, enhancements through final completion. This function acted as a key liaison with respect to product development with prospective suppliers and existing suppliers in order to assure a high degree of technical accuracy and completeness. Responsible for continuous search for new materials and process improvements for product line.

Injection Molding Manufacturing EngineerResponsible for all manufacturing operations for molding, assembly, bonding, and secondary operations related to silicone molding operations. Other responsibilities included trouble shooting of molding operations for injection, transfer, and compression molding operations. Additional requirements included implementation of support documentation for production area, writing of bills of materials, engineering change notes, per standard operating procedures to insure compliance and improve process efficiencies. Also, new product engineer for long term implantable defibrillators. In addition, supported other new products for all leads and pacer engineers who required silicone molded components.

Boston, Ma, Us

Setup and implemented quality plan for extrusion and vacuum forming processes in high volume production environment. This encompassed (4) co extrusion lines and (4) rotary and inline thermoforming machines. Developed critical to quality parameters for extrusion process and maintained this system on a daily basis. Worked on various projects to reduce scrap and programs to improve yields and efficiencies. Trained extrusion operators on SPC and initiated SPC to track machine functions routinely.

Troubleshoot compression molding operation for thermoset sheet molding compound. Established machine setups and molding parameters for new product lines.

Supervised molding operation of 15 compression molding machines and 60 hourly UAW employees in a high volume automotive production environment. Supervised molding, trimming routing, bonding, and secondary assembly operations of plastics materials processing