Project Manager Quality Systems

Professional Summary

Technical contributor in Medical Device Engineering, Manufacturing, Compliance and Quality Systems with full time and contract assignments.

Proven effective leader to engineering and cross-functional teams.

Technical competence in mechanical product design, PLM, quality, and manufacturing processing

Well versed in 21CFR820, ISO13485, ISO9001, GMPs. Slightly less with MDD/ MDR.

Skilled in remediation: reviewing and updating older documents to meet current regulatory guidelines, industry standards and client company requirements.

Written and verbal communication skills

Demonstrated success in short–term contracts where walk-on expertise is needed:

oBuilding Relationships, Team Lead

oMedical device product development and remediation

oPre- CAD part design and Design for Manufacturability

oEquipment validations

oCompliance and tech writing SOPs and Quality Systems documentation

Skills

Management: Project Manager, CAD Group Manager, Change Control /Document Control Group Manager

Compliance: FDA Quality Systems development and trainer, phase/gate design controls, Design History Files, remediation, CE Marking / ROHS, FMEAs, validation, risk management, technical writing, Change Control, CAPAs, 483 remediation, GxPs, ISO Quality Systems / EU MDD/MDR.

Technical: New Product Development (NPI/NPD) w Phase/Gate methodology, Technology Transfers, Process and Equipment Validation, Gauge R&R, IQ/OQ/PQ, FMEAs, Temperature Mapping, Process Optimization, Technical Writing/Process Mapping, Mechanical design for injection molded, machined parts, E/M assemblies, GD&T, BOMs.

Tools: MS Word, Excel, Project, PowerPoint; PLM/PDM tools, Agile, E1, MRP/ERP systems, Smartsheet, QCBD, Maximo, Six Sigma Green Belt/DMAIC

Business: Plant and technology transfers; Scheduling, vendor selection, Capex. Offshore manufacturing in Mexico, China, Germany,

Professional Experience

PTO Carlsbad CA November 2023 to Current

Personal time off for family matters.Aug 2024: Currently looking for new work.

Gilero, Carlsbad CA January 2023 to October 2023

Sr. Project Manager: Medical Device Contract Design and Development House

Managing a $1.5million pain management combination product (drug delivery device) design for client’s FDA submission. Supporting resources and removing barriers.

Delivery included driving the engineering elements of CAD part designs and Bills of Materials, liaising with the off-shore injection house for first articles and metrology; designing, building, engineering verifications of assembly fixtures and transfer for off-shore assembly. Reviewed design requirements and SOPs.

Medtronic Neurovascular Irvine CA January 2022 to June 2022

Project Manager: Remediation (contract)

Selected to be the group PM: Facilitating, scheduling, and coordinating the development, CAPA management for revisions to legacy documents by a team of engineers all working remotely to remediate for compliance to current MDD/MDR, FDA and corporate CAPAs for process optimization expectations.

Liaise with client to coordinate R&D. Quality Engineering and Regulatory reviews with LIVE reviews and TEAMS meetings to understand and address logistics and technical issues.

Manufacturing Engineer; Remediation (contract)

Performed deep dive gap assessments, recommending process optimization, and writing validation reports to previously approved engineering changes for accuracy and completeness to support risk management and 483 concerns. Updated SOPs to meet current QSM requirements.

Dexcom, San Diego, CA July 2021 to December 2021

Equipment Systems Engineer; Equipment Software Configurations (contract) Medical Device R&D /Manufacturing - 75% Remote

Verified third party PLC and HMI software documentation and installation to an automated production line for a high-volume continuous glucose monitoring Class 3 device.

Becton Dickinson/ Carefusion, San Diego, CA October 2020 to June 2021

Project Manager (contract) Medical Device Engineering and Manufacturing - 100% COVID Remote

Managed a cross-functional remediation team of R&D, Marketing, Quality, Manufacturing, Medical Affairs, Regulatory and other professionals for CAPAs on legacy documents for compliance to current MDD/MDR, FDA and corporate policy for single use infusion tubing sets.

Abbott Rapid Diagnostics/ Alere, San Diego, CA August 2019 to October 2020

Equipment Engineer (contract) Medical Device Manufacturing and Assay Laboratory Facilities - 75% COVID Remote

Created new and revised preventive maintenance protocols with process mapping for facility/ physical plant utilities.

Wrote, revised, and reviewed legacy documentation: User Requirements (URS), Functional Specs (FS), Detail Design Specs (DDS)

Revised/Updated IQ and OQ documentation.

Communicated with service providers, suppliers, and equipment operations manuals to create procedures and checklists.

Championed the effort to complete electronic records for scheduling preventive maintenance, Work Order management to archive PM completion records and document service provider training.

Sorrento Therapeutics, San Diego, CA August 2018 to August 2019

Facility Validation Engineer: Controlled Temperature Units (contract) Antibody and cell therapy R&D and manufacturing

Drafted and executed IQs, OQs on incubators and freezers utilizing data loggers for temperature mapping, along with bio-safety cabinets, offline bench-top instruments.

Generated procedures and specifications for calibration, maintenance, and equipment qualifications (IQ/OQ/PQ)

Performed a gap analysis on Lab equipment calibration and PM records for transfer to electronic database (QCBD)

Physio Controls, A Division of Stryker, Redmond, WA April 2018 to August 2018

Project Engineer: EU/MDR Labeling (contract) Defibrillator Manufacturing (Task specific short-term contract)

Analyzed and documented gaps; facilitated reviews; coordinated team member Action Items for a labeling integration project to upgrade current EU product and package labeling for compliance, symbols, and new corporate ownership.

Vesta Inc division of Lubrizol, Milwaukee, WI February 2018 to March 2018

Validation Engineer: Quality System Processes (contract) Medical Molding, Extrusion & Assembly contract Manufacturer

Originally a 3-week assignment to remediate, review and recommend CAPA improvements to the QSM for IQ and OQ protocols. contract extended to create new procedures with process mapping to improve compliance and GMP practices.

Virbac Animal Health, St. Louis, MO October 2017 to February 2018

Validation Engineer: Production Line Equipment (contract) Animal Pharmaceutical Products (Task specific contract)

On the team of contractors to commission a form/fill/seal and package line for a solid oral dose product.

Wrote and/or executed equipment URS, IQ, OQ, and facilities documents for mixers, extruders, in-line inspection, blister packaging and carton packaging equipment.

Philips Healthcare, Andover, MA February 2017 to June 2017

Validation Engineer: Manufacturing Processes (contract) Medical Molding, Extrusion & Assembly contract Manufacturer

Performed data mining/gap analyses with recommendations to improve production processes and procedures by auditing closed CAPAs for indications that ‘risk of reoccurrence” had been considered and sufficiently mitigated.

Distinguishing functional testing from performance testing for compliance with 21CFR820 regulations.

Cook Medical, Bloomington, IN November 2016 to February 2017

Project Manager: Remediation (contract) Implantable Orthopedic devices

Lead several teams chartered to revise and update QSM Production and Process Control documents to be compliant with FDA regulations in Production Processes, Equipment, Process Validation, Labeling and Post Sterilization areas.

Levitate Technologies, San Diego, CA June 2016 to October 2016

Project Manager: ISO Compliance (contract) Ergonomic Lifting Assist Device (Task specific contract)

Developed and established the ISO 9001:2015 Quality Management System for this non-medical startup. Drafted the QSM, SOPs and forms for relevant clauses preparing the client for their stage 1 audit.

Coordinated and facilitated management reviews. Researched vendors for CE mark certification

Acushnet Golf, Carlsbad, CA April 2016 to June 2016

Technical Writer: Manufacturing Processes, SOPs (contract) Titleist Golf Clubs

Created /documented manufacturing SOPs with process mapping based on observation and communications with production operators and supervisors. The project goal was to reduce rework and rejections through standardizing operator techniques. SOPs included detailed production and inspection steps with photos and checklists.

Zimmer Biomet, Warsaw, IN February 2016 to April 2016

Project Manager: Quality Systems (contract) Orthopedic Implants Quality Systems assimilation

Created the project plan, established a team to integrate a business unit’s CAPA records into the corporate database.

Alere (now Abbott), San Diego, CA September 2014 to February 2016

Project Manager: Technology Transfer (contract) Toxicology products facility transfers, shutdown, product development

Directed and completed three separate technology transfers. Beginning with gap analysis of Quality System documents of the originating facility and the facility assuming production; lead team members in both locations. Executed plant shutdown by coordinating third party resources, project plans, on time delivery and budget/project financials.

Project Manager to upgrade an in-vitro diagnostic product developing new assays to improve production processes.

Carefusion (Now BD), San Diego, CA October 2013 to July 2014

Project Manage: MDD/MDR ROHS Compliance (contract) Infusion Pumps (EU Compliance)

Using MS Project to Develop the plan and successfully drive to completion a highly accelerated ROHS compliant (MDD 93/42) project. Lead a matrix managed team of multiple disciplines of offshore and on shore engineering, operations, quality, sourcing and regulatory for a Class II medical device. Approximately 10,000 mechanical and electronic parts specifications reviewed and analyzed for elevated levels of the 6 ROHS substances defined by the EU

Coordinated resolution of technical issues with domestic and offshore suppliers, In-house supply chain, in house V/V testing, hazards review, risk analysis, drawing changes, certificates of compliance, and a multitude of project control documents for DHF and Device Master Records

ViaCyte, San Diego, CA July 2013 to October 2013

Development Engineer (aseptic packaging contract) Implantable Regenerative Medicine / Diabetes device

Documented aseptic sterile barrier and external packaging to ship live material worldwide. Worked with vendors to establish sterility verification requirements and performance testing on packaging and shipping containers. Developed process FMEAs on product packaging.

Zimmer Dental, Carlsbad, CA May 2012 to July 2013

Manufacturing Engineer (contract) Dental Implants Design and Manufacturing

equipment compliance remediation)

Managed, executed, and reported CAPA/ 483 production equipment remediation.

Drafted and dry-ran Validation methods using IQ/OQ/PQ methods for optical comparator and labeling equipment.

Stryker Sustainability Solutions, Phoenix, AZ March 2012 to June 2012

Project Engineer (contract)

Remanufacturer of “single-use” medical equipment {R&D activity) (Task specific short-term contract)

Reverse engineered single-use laparoscopic instrument for consideration as refurbished equipment for surgical training.

Significant Experience in order of growth / professional experience prior to 2012

R&D Mechanical Drafting and Design (metals and plastics), Pre-CAD

Document Control Revision Management and BOM reviews, CAD, Change Management Group Manager

NPI/NPD Project Manager for an IVD device

Manufacturing Program Manager, hi volume disposable contract manufacturer

Process Validation Engineer reviewing IQ/OQ/PQ, facilitating FMEAs.

Technical writing of SOPs, work instructions, Quality System documents

483 Compliance Validation Engineer

Professional Associations

Association of Configuration and Data Management (ACDM) Board of Governors, 1997 to 2002

Education

Rhode Island College, Providence, Rhode Island

Bachelor of Science, Industrial Technology and Education

with studies at

West Virgina State University, Institute, WV

Jagellonian University, Krakow, Poland

Nichols Institute Diagnostics

Green Belt Certification

Other

BSA Eagle Scout

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