Jean Bishop Email and Phone Number

General Consulting for Medical Device Quality Compliance Engineering

• Created and maintained product Risk Management Files supporting design and regulatory controls for dental products.• Managed Electrical Safety (UL, TuV, Intertek) and other outside testing services for multiple dental products. Coordinated submissions of product and documentation to agencies and followed projects through completion.• Key team member supporting Technical Documentation Files and regulatory submissions for EU MDR compliance for multiple dental product lines including technical reviews and writing of Clinical Evaluation Plans/Reports (CEP/CER), Periodic Safety Update Reports (PSUR), Post Market Clinical Follow-up Plans (PMCF), and Risk Management Files (RMF). • Managed biocompatibility, microbial and sterilization validation test plans, reporting, and regulatory related content included with submissions.• Participated in multiple Quality Systems (ISO 13485, MDSAP) and Technical Documentation File (EU MDD and EU MDR) Audits; SME on design controls, design history files, and risk management.

• Responsible for all aspects of quality management including design, software, and product quality assurance, quality engineering, supplier quality, CAPA, inspection, and internal and external auditing. • Supervised document control and served as management representative.• Implemented and integrated HHS Center for Medicare and Medicaid Services (CMS) Quality Systems Standards requirements for durable medical equipment (DME) into a FDA approved (21 CFR 820) quality system over a 3 month time-frame. Wrote and modified policies and procedures and obtained approval from accrediting organization.

• Defined product and technical requirements including mechanical, electrical, software, materials, labeling and user documentation, and regulatory compliance.• Managed compliance testing and assured compliance to design control procedures.• Served as quality representative on project teams. Reviewed document changes, determined verification test requirements, wrote and reviewed verification test plans and reports. Participated in CAPA and MRB activities. Applied statistical test methods in design V&V and reliability test reports. • Conducted ISO 14971 compliant product risk and hazard analysis and DFMA including traceability matrices for new and existing product designs.

Created detailed component purchasing specifications and BOMs and entered into material management system.

• Obtained certification for the company as an ISO 17025 test laboratory authorized to conduct IEC 60601-1 and IEC 60601-2-37 safety testing under the category test program (cUS and CB scheme). • Managed $300K department operating budget, project plans, schedules, and allocated resources to projects per plan. • Achieved IEC 60601-1:2005 (3rd Edition) product safety certifications for 4 medical products and 2 medical accessories in one year. Initiated and completed IEC 60601-1 (2nd Edition) testing and safety submissions. Total of 23 C/US and/or CB submissions and 16 approvals within 1 year.• Managed quarterly electrical safety factory and ISO 17025 quality system audits. • Served as in house electrical safety consultant/advisor for project teams during new product development. Determined applicable/required compliance standards and communicated content and requirements including system level, module level, OEM, and label/user document content to design team. Represented department function at design/phase reviews. • Conducted risk/hazard analysis, product testing, and wrote and reviewed complex safety test, V&V and engineering test plans, procedures, reports.

• General Consulting for Medical Device Quality Compliance Engineering. Some projects included the following:• Within 4 months, created a quality system for a start-up medical device company sufficient for entry into human clinical trials including writing SOPs for the elements of Design Controls, Document Controls, Risk Analysis, Verification and Validation, Tool and Equipment Control, and Training. Created and implemented plan for full QSR/ISO 13485 compliance, drafted a Quality Manual, system level SOPs, and conducted employee training. • Provided project and operations management services for relocation of medical device manufacturing companies to new facilities. Managed set up and operation of an interim satellite training facility and tooling, allowing the client to expand capacity on schedule. Generated and managed project plans and schedules for moving ISO Class 8 cleanroom operations/production, reviewed engineering, cleanroom qualification and commissioning documents, and managed facility moves with no impact on production plan or inventory levels; multiple companies and moves. Wrote and conducted tool and equipment qualification protocols and reports (Inspection, Calibration, IQ, OQ, PQ, PPQ).

• Key member of 4 person management team overseeing and supporting over $2 million in annual sales of a micro-miniature medical fiber optic pressure sensor and support system.• Hired, trained, and supervised manufacturing and operations team.• Designed, wrote, and implemented the corporate document control system compliant with ISO and 21 CFR 820 quality regulations. • Defined product specifications including software requirements. • Wrote and conducted process and product software verification and validation procedures.

Created processes and procedures for the design and manufacture of a drug/device combination product for the treatment of advanced cancers using photo-dynamic therapy (PDT).

• Performed design quality engineering function for re-engineering and manufacture of an implantable spinal cord stimulation system for pain management. Created product, test, material, and performance specifications and guided team in verification, validation, and regulatory submission support documentation and reports.• Lead team in performing Risk and Hazard analysis and FMEA, and conducted system validation testing for new generation product systems.• Created a new quality management system, as a spin-off company/medical device manufacturer. As member of a 3 person team, wrote and implemented SOPs including Design Controls, Verification & Validation, Document Format and Content, Supplier Quality and Auditing, Statistical Methods, and Quality Planning.

• Designed and implemented assembly line layout utilizing manufacturing cell methodology. Implemented “pull” system manufacturing and balanced process flow resulting in improved labor utilization (10%), increased capacity (20%), decreased throughput time (days to <4hrs), decreased floor space requirements (35%), and decreased WIP (>$100,000). • Conducted process validations and cleanroom commissioning, and operational and performance qualifications and validations.