Lauretta MacColman
Details
Capsa Healthcare
Quality Assurance Manager and Information Security Officer
Establish and deploy ISO 9001 program.
2022 : 2022
Self Employed
Retired
Medical device component supplier for stent guidewires.
2011 : 2012
Precision Wire Components
Supplier Quality Manager
Managed a team of 9 professional and hourly reports for a $100 million mission critical battery pack and charger supplier. Responsible for a budget of $xx
Management representative for FDA and ISO 13485, 9001 compliance. No major findings or 483's. Lead successful addition of ISO 13485 certification.
Fortune 100 companies.
Managed Incoming and Final Inspection, Documentation, Regulatory inspections, RMAs, MRB.
Directed quality relationship for over 200 suppliers including 4 Asian Contract Manufacturers, 4 major PCA suppliers and dozens of plastic and cell suppliers.
2005 : 2011
Micro Power Electronics
Quality Manager
Developed new quality management system for a startup after-market high technology repair and service company. Obtained ISO 9001 certification. Identified and developed key measurement systems. Supported the development of new accounts.
2003 : 2005
Teleplan Services Oregon, Inc
Quality Engineer/Manager
About
Retired. Formerly experienced quality assurance professional consistently delivering successful programs. Managed quality systems in a varied environment including: Medical, Military, Automotive, Telecommunications and Nuclear Quality Assurance experience. Strong business background as a key Operations Manager and Executive Staff positions for a wide range of industries and size corporations with multiple locations. An effective leader able to manage diverse groups and facilitate change. Established history of managing customer operations and supplier quality. Experience managing global suppliers.
Specialties: * ISO 9001 * ISO 13485 * Lean Black Belt Six Sigma * Supplier Quality * Documentation & Metrics * Regulatory * Inspection & Test * Corrective Action
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