Margaret R. Heuser, CQA
CAREER SUMMARY
Experienced manager and scientist with extensive background in regulatory assurance, quality management, manufacturing/assembly, process development, audit systems, and production management. Skilled team player and self-motivator with excellent analytical and communication skills.
EXPERIENCE
2002-2003
CHS Business Associates LLC, Avon, OH
Cleveland-based consulting firm with over 70 years combined experience in the medical device arena with expertise spanning the entire life cycle.
Vice President Quality and Regulatory Affairs
Responsible for project definition, proposal and completion primarily focused on Quality Systems and Regulatory Affairs.
- Validation Improvement Project for large medical device manufacturer including conducting gap analysis across 6 sites and 2 business units. Worked with cross-functional team to develop global operating procedures for software, process and design validation and developed CD-based training modules for employee training.
- Conducted FDA compliance audit for local contract medical device manufacturer and worked with employees to develop or improve procedures to address primary compliance issues including validation, 21CFR Part 11 and design controls.
- Conducted 21CFR Part 11 compliance audit for large medical device manufacturer.
1988-2000
Bayer Diagnostics, Oberlin, OH
Formerly known as Chiron, Ciba-Geigy, and Ciba-Corning. $2 billion, 7,500 employee medical diagnostics division of Bayer Group headquartered in Leverkusen, Germany.
Manager, Quality Initiatives and Regulatory (1995-2000)
Responsible for facility compliance to FDA (Food and Drug Administration) and ISO 9001 requirements, $360,000 budget and plant health and safety role. Managed internal and external audits and trained new and existing employees on regulatory requirements. Worked on several projects and programs including the Centaur instrument release, allergy assays, and Quantiplex instrument development and release.
- Completed one successful FDA audit and 3 successful ISO Surveillance/Certification audits.
- Scripted, recruited and taped "Oberlin Regulatory 101" training videotape for employee base.
- Managed customer complaints and field corrections including customer notifications and FDA communications.
- Member of Quantiplex instrument transition team representing quality and regulatory functions.
- Reviewed and compiled records necessary to support Centaur and Quantiplex instrument FDA submittals.
Process Manager, Test and Calibration (1994-1995)
Managed and led the test and calibration areas of the instrument manufacturing floor, including $1.5 million budget and up to 32 technical and professional employees. Responsibilities include utilization of engineering, planning and purchasing resources to meet business demands in a team-based, continuous improvement environment. Led process teams using problem solving techniques including Pareto, cause/effect diagrams and flow mapping to guide activities.
- Addressed process issues which resulted in a 37% decrease in cycle time and a 30% improvement in first pass yield.
- Manufacturing leader for Centaur floor layout team resulting in efficiency and safety improvements.
- Developed concept and requirements for WIP (work in process) and APV (assay performance verification) troubleshooting Lotus Notes databases.
- Implemented Calibrator/Test Technician cross training process which allowed for employee development and improved efficiencies during volume fluctuations.
Manufacturing Supervisor (1992-1994)
Led and managed the assembly of in vitro diagnostic instruments using Good Manufacturing Practices in a team-based environment. Responsibilities included $1 million budget, up to 35 employees, production scheduling, inventory accuracy and continuous improvement activities.
- Established center aisle inspection team, eliminating the need for Quality Assurance inspection while improving cycle time and first pass yield measures.
- Achieved continuous improvement activities realizing a 25% improvement in cycle time in one year.
- Implemented and led natural work teams responsible for scheduling, quality and prioritization.
Quality Control Manager, Reagents (1990-1992)
Member of self-empowered team operating the Clinical Chemistry Reagent business unit. Managed and led all diagnostics quality control functions for raw materials, in-process, and final products for the Oberlin facility. Designed protocols and directed studies for QC, R & D and customer service groups.
- Implemented changes to manufacturing process that effected a 48% decreased in blend reworks.
- Worked with Reagent Engineering to develop a multidisciplinary team approach to product development which resulted in a 30% decrease in development time.
- Joined company as a Quality Control Chemist and promoted three times within four years (1988-1990).
1982-1988
Medical Technologist
1986-1988 St. Joseph Hospital, Lorain, Ohio
1985-1986 Clinical Health Laboratories, Euclid, Ohio
1982-1984 Mercy Hospital, Toledo, Ohio
Responsible for accurate test results, timely result reporting, instrument maintenance, phlebotomy, student training, and quality assurance.
- Created numerous written test protocols to comply with regulatory requirements and aid in student training.
- Trained Lorain Community College Medical Laboratory Technician students.
PROFESSIONAL ASSOCIATIONS
American Manufacturing Association
American Society for Quality
Regulatory Affairs Professionals
AdvaMed
CERTIFICATIONS
Certified Quality Auditor
American Society of Clinical Pathologists - Medical Technologist
EDUCATION
MBA, Executive Program, Baldwin Wallace College, Berea, Ohio
BA in Medical Technology, University of Toledo, Toledo, Ohio
ADDITIONAL TRAINING
New GMPs for the medical device industry
Facilitator Training
Zenger-Miller Frontline Leadership and "Working Program" for managers
Teambuilding Seminars
Software Requirements for FDA & ISO
Software Verification and Validation
Risk Assessment and Hazard Analysis