Quality Engineering Product Development

Sheryl O’Brien

320-***-**** *******@*****.*** ***51 80th Street, Milaca, MN 56353

Experience

CIRTEC MEDICAL QUALITY MANAGER DECEMBER 2023 – PRESENT

Medical Device Contract manufacturing for components and finished devices. - Class II & Class III medical devices.

Operations Quality Engineering support (manufacturing).

New Product Development - Solution provider for complex engineering projects in a fast-paced environment.

Management of engineers and inspection teams (30 total employees) for the company.

Quality Systems Management representative for internal and external audits including FDA inspection.

CAPA leader and coach

Support for continuous improvement projects and initiatives.

ABBOTT LABORATORIES/SJM QUALITY ENGINEERING MANAGER JUNE 2015 – NOVEMBER 2023

Medical Device Divisions supported: Structural Heart, Electrophysiology, Neuromodulation - Class II & Class III medical devices and accessories

Operations Quality Engineering (manufacturing) - Development of Quality plans, validation protocols (IQ, OQ, PQ, PPQ) including Master Validation strategies, procedures, and manufacturing processes

New Product Development program manager - Solution provider for complex engineering projects

Supplier Quality Engineering manager for multiple sites

Management of engineers and inspection teams including contractors (23 total) for the division

Quality engineering support for manufacturing and distribution centers

Abbott CAPA certified, leader and mentor across multiple divisions

Quality System improvement leader

Responsible for Regulatory and audit compliance support for internal, external audits (BSI - ISO 13485, Microbiology, Country Specific Audits, FDA)

Established and reviewed Quality Agreements with external and internal suppliers

Supported cost saving initiatives, acquisitions, and continuous improvement projects with global impact

GLOBAL TRAFFIC TECHNOLOGIES QUALITY MANAGER JUNE 2013 – JUNE 2015

Quality, Safety and Compliance Manager

Developed and managed a global level quality and compliance program

Quality management process owner for the new product development programs

Management of contract manufacturers and development of a supply chain program

Completed ISO 9001:2008 recertification audits with no audit findings

Maintained a service and repair department with a 98% customer satisfaction rating

Safety manager who was responsible for developing and maintaining the company health and safety programs

HEARTH AND HOME TECHNOLOGIES SR. SUPPLIER QUALITY ENGINEER SEPTEMBER 2012 – JUNE 2013

Supplier Quality Engineer responsible for supplier evaluation and management

Developed quality audit program and achieved measurable improvement and cost savings with a diverse supply base

MELLO SMELLO DIRECTOR OF QUALITY MAY 2010 – MAY 2012

Developed and implemented an ISO compliant Quality System - Established quality policies and procedures

Represented the company during audits and improved customer relationships

Managed multiple site compliance to FDA and cGMP for this printing and packaging supplier

Established a plant training and change management process

SQA SERVICES LEAD SUPPLIER QUALITY ENGINEER JANUARY 2010 – SEPTEMBER 2010

Worked with Medtronic Neuromodulation and Rockwell Collins in providing Supplier Quality Assessments and improvement projects

Guided suppliers in the development of control plans, PFMEA, SPC and process validation (IQ, OQ, PQ)

Experience (cont.)

TEAM INDUSTRIES SUPPLIER QUALITY ENGINEER JANUARY 2007 – SEPTEMBER 2009

Created the Supplier Quality program

CAPA leader who improved relationships with both suppliers and internal customers

ISO 9001 Internal Quality Auditor and quality system management leader

ROBERT HALF TECHNOLOGY IT CONSULTANT JANUARY 2002 – JANUARY 2007

Network Infrastructure Development

Site Management, budgeting, and management of external suppliers

Business Systems Analyst for HealthCare remediation team

SHELDAHL INC SENIOR TECHNICAL ANALYST 1995 - 2001

Quality Engineering and Research support

Enterprise IT support

ADVANCE POSSIS TECHNICAL MEDICAL DEVICE CONSULTANT 1994 – 1995

Surgical Instrument Technician

Quality Assurance for instruments used in vascular, orthopedic and neuro surgical applications

DAYCO PTI QUALITY ASSURANCE TECHNICIAN 1987 - 1994

Quality Engineering technician and Research support for automotive industry supplier

Education

BACHELOR’S DEGREE – BUSINESS COMMNICATION UNIVERSITY OF WISCONSIN – RIVER FALLS

Coursework in Business Administration and Communication

ASSOCIATE DEGREE – ANIMAL SCIENCE/ANIMAL HEALTH UNIVERSITY OF MINNESOTA – WASECA

Animal Science Major with emphasis in animal health

Skills and Accomplishments

SKILLS

Quality Engineering Management: Management of employees, manufacturing quality processes and deliverables

Quality Systems Development and Sustainment: Development and support of quality systems across global sites

Quality Planning and Regulatory Compliance: Medical Device, Automotive, Aerospace industries

Systemic Problem Solving: NCMR, CAPA, SCAR, SCR experience

New Product Development – New Product Development Engineering Manager for Medical Device company

Validation – Protocol creation, execution, review, and trainer

Medical Device Manufacturing – Quality Engineering manager for major medical device companies

Engineering and Supply Change Manager – Provided engineering solutions and managed change in global supply chain operations.

Certifications: Abbott certified CAPA – Initiator, Investigator, Resolution Plan Developer and Approver, SQA Services associate and auditor certification, ASQ Certification, Microsoft Certified Professional

Software: Microsoft Office, EPIQ, SAP, Minitab, CATsWeb, WindChill, Agile

Processes: NCMR, CAPA, SCAR, SCR, Non-Conformance, Medical Device regulations, ISO 9001, ISO 13485, Quality Planning, Process Development, Design Input, Design Selection, Design Verification and Validation, Process Validation IQ/OQ/PQ/PPQ

ASSOCIATIONS

American Society of Quality (1995 – Present)

Midwest Global Trade Association (2013 -2015)

American Endurance Ride Conference – Welfare committee (2016 – Present)

Upper Midwest Endurance and Competitive Ride Association (2001 – Present)

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