Peter Nye Email & Phone Number

Sunnyvale, California, Us

Danville, California, Us

QA consultant for medical device companies (FDA Class II and III, EU Class IIa, IIb and III):-Held Management Representative (MR) role for respective clients-Managed, implemented, improved and maintained clients' Quality Management Systems (QMS)-Implemented compliant QMS catered to needs of the client-Led preparation efforts for external audits and inspections-Led internal audits: FDA , ISO 13485/14971, 93/42/EEC (EU), SOR/98-282 (CA), RDC 16/2013 (BR)-Authored/approved DCOs: justifications for change, impact assessments and material disposition-Established and maintained Training ProgramDesign and Development:-Managed: User Needs/Inputs, Outputs, Verification, Validation, Transfer and Commercial Release-Led Design verification testing: biocompatibility, sterilization, transit testing, and shelf life/aging-Managed Risk Management activities: planning, HA, FMEA and reporting-Assisted with label/ IFU and packaging design-Assisted with DHF, TF and Design Dossier creation, review and updatesPost-Market/Improvement:-Initiated and investigated NCMRs-Authored and implemented Deviation Requests-Managed RMA processes-Managed Customer Complaints and AE Reports/MDRs-Led CAPA investigations-Led Health Hazard Evaluations to assess risk associated with discrepant product in the field-Led Product Recalls and correction efforts for clientManufacturing/Operations - Established, improved and maintained:-Purchasing and Supplier Controls-Material Controls process-Inspection and manufacturing processes, procedures and documentation-Inspection and manufacturing record review process-Finished Goods product release-Equipment Management program, including Calibration and Preventive Maintenance-Clean Environment Room setup, validation, control and monitoring per ISO 14644-1/-2-Bioburden Monitoring, Bacterial Endotoxin monitoring and Dose Audits-Equipment Qualification and Process Validation activities

Santa Clara, California, Us

-Managed Sr. Quality Specialist in daily activities relating to device history record (DHR) review and approval, batch release, supplier batch paperwork review and approval, calibration/preventive maintenance and quality data trending -Helped manage Quality Engineer in daily activities relating to engineering change order (ECO) review and approval, incoming inspection review and release, audit nonconformance management and nonconforming material management-Helped improve engineering change order process -Managed processes for internal audits, corrective and preventive actions, quality data trending-Authored, reviewed and approved engineering change orders for design, manufacturing and quality management system documentation-Authored, reviewed and approved nonconforming material reports-Authored, reviewed and approved out-of-tolerance tool reports and environmental monitoring excursion reports-Authored and revised standard operating procedures, supplemental procedures and forms for quality system processes such as complaint handling, medical device reporting, returned goods authorization, servicing, corrective and preventive action, document/change control, product release, regulatory agency inspection, sterilization, calibration/preventive maintenance, internal and supplier audits, supplier controls, nonconforming product, deviation authorization, training, inventory control, etc -Participated in design reviews and helped facilitate closure of design project and design history file for endometrial ablation system-Implemented electronic medical device reporting (eSubmitter and Electronic Submissions Gateway).-Authored quality system training material for sales professionals-Participated in FDA premarket approval inspection

St. Paul, Mn, Us

-Established/implemented clean room and production floor production processes for Pearland facility-Established/implemented Pearland facility quality management system-Managed/maintained clean room ISO Class 7 certification-Authored, reviewed and executed equipment qualification/process validation protocols-Trained production and quality control employees -Supervised/managed production and quality control employees during an interim period-Authored, reviewed and approved nonconforming material reports (NCMRs) -Initiated and investigated corrective and preventive actions (CAPAs)-Investigated production quality issues and assessed need for corrective and preventive action.-Managed calibration and preventive maintenance activities-Addressed out of tolerance conditions related to calibration control and preventive maintenance -Managed environmental monitoring activities including particle counts, biological monitoring, bioburden testing, pyrogen testing, temperature and humidity monitoring and differential pressure monitoring-Authored, reviewed and approved engineering change orders -Authored, reviewed and approved standard operating procedures, departmental procedures, work instructions, manufacturing process instructions, quality inspection procedures, design failure mode and effects analyses, process failure mode and effects analyses, design drawings, equipment drawings/specifications, engineering documents and technical documents-Authored, reviewed and approved deviations -Authored and reviewed health hazard evaluations -Lead auditor and co-auditor for internal quality management system audits-Assisted with investigation and implementation of supplier requests for change-Participated in Intertek/ISO surveillance and recertification audits-Participated in FDA surveillance inspections-Participated in internal audits-Manufacturing Quality representative on product development teams-Authored and reviewed post-market surveillance reports

Naples, Florida, Us

Quality assurance representative on product development teams:-Attended and participated in design reviews-Performed complaint analyses on internal and external predicate devices to provide qualityrelated design inputs-Spearheaded risk management activities - risk assessments and dFMEAs-Authored and implemented inspection and testing procedures for quality control-Reviewed and approved design outputs-Authored, reviewed and approved design verification and design validation activities-Reviewed, organized and approved design history files-Participated in design transfer activitiesPerform post-market surveillance activities:-Investigated complaints for Class I and II devices-Trended complaint data to determine necessity for corrective measures-Investigated and approved material review board (MRB) reports-Trended MRB data to determinenecessity for corrective measures-Supplier contact for deviation requests and process related change requests-Monitored supplier related issues to determine need for corrective measures-Reviewed and approved post-transfer design changesAdditional Activities:-Performed Internal audits of quality system components and production processes atmultiple locations to ensure compliance with cGMP/QSR and ISO regulations-Performed supplier audits for qualification and re-qualification against cGMP/QSR and ISOregulations-Reviewed and updated quality control inspection and testing references and procedures-Assigned and monitored corrective and preventive action (CAPA) requests-Authored and executed IOQ/PQ protocols and reports for production and quality controlequipment and processes

Tempe, Az, Us

Quality Assurance Representative in design, manufacturing and post-market surveillance-Investigated customer complaint reports -Developed, implemented and assessed corrective measures-Designed, implemented and updated production processes and procedures-Performed internal audits of quality system components and production processes atmultiple plants to ensure compliance with cGMP/QSR and ISO regulations-Participated in KEMA/ISO surveillance and recertification audits-Quality Assurance representative in risk management meetings-Assisted in FMECA analysis-Participated in LEAN Manufacturing/KAIZEN activities-Authored and executed IOQ/PQ protocols and reports-Performed bacterial and microbial monitoring tests

Assisted in Cadaver Trials for Various Medical Devices -Assisted doctors in studies relating to medical device implantation, minimally invasivesurgical approaches, medical imaging and other procedures.-Operated fluoroscopy systems, suction devices and video equipment