. Audit, review, and critique most lean related manufacturing technologies.
. Revise, prepare, audit, review and critique QA and QC programs and documentation to ensure quality
. Provide QA Mfg and test support for Mfg floor and contract vendor production lines.
. Provide information and support for ongoing product design and new product design review boards.
. Audit, review and critique all QSM, SOP, EC related protocols and documentation.
. Audit, review and critique all IQ, OQ, PQ, PPQ related protocols and documentation.
. Audit, review and critique all QC Mfg related protocols and documentation.
. Audit, review and critique Risk Management program and deliverables FMEA’s, FTA’s, etc.
. Audit, review and critique manufacturing program procedures, sampling, and processes.
. Participate and represent Regulatory in Design and Manufacturing meetings. ECO, DRB, MRB, etc.
. Train and Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes.
. Work with ISO/EN/CE, FDA, and other Agency documentation and Qualifications.
. Revise, prepare, audit, review and critique Multilevel SOP, BOM, and ECO process instructions and records.
. Audit, review and critique SPC and QC/QA related protocol and documentation
. Skilled in New Product Introduction, NPI and ISO/ EN / certification processes.
. Audit, review and critique validation SOPs and policies according to cGMPs for aseptic process validation,
sterilization validation steam, gamma, EtO, dry heat, etc..
. Audit, review and critique Large and small vendors for setup and Transfer of products to vendor sites.
. Audit, review and critique schematics, blueprints and build instructions fort both Electrical and mechanical
. Proficient in MAC/PC Applications: MS Windows, MS Office, Word, Excel, PowerPoint, etc.
. Audit, review and critique purchasing control records and operations
. Audit, review and critique Software and Hardware validation.
. Audit, review and critique Failure mode effect analysis of product design specifications and documentation.
. Monitor, maintain, audit, review and critique Corrective action and process document processes.
. Audit, review and critique Design review FMEAs and risk management for product design analysis.
. Audit all major test equipment such as scopes, logic analyzers, spectrum analyzers, etc..
. Audit all major production equipment such as CNC machines, packaging machines, sterilizers, etc..
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Nonmechanical Medical Devices
Durable, Electronics, Implantables, IVDs, Lasers, Software, Cataract systems, Oncology systems, Coated Stents,
Steerable Catheters, Over the wire OTH, Rapid Exchange RX Stent delivery systems STS, Pacemakers,
Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits
Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique QSIT/ Quality System
Regulation QSR, Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; CFR
Part , FDA, FDA and Warning Letter Responses/Consent Decree, GAMP, Hazard Analysis, ISO /
// / Risk Management/ Active Implantable Medical Device Directive AIMD / Invitro
Diagnostic Directive/ Medical Device Directive MDD, OSHA, , Quality Assurance, Quality Control, Quality
Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations.
HIGHLIGHTS OF QUALIFICATIONS
Medical Device Compliance Results Oriented Problem Resolution
Failure Modes & Effects Analysis Strong Negotiation Skills Strategic Planning
Excellent Communication Skills Team Player and Leader Project Management