Operations Manager Resume

SUMMARY

Operations Manager and Quality Engineer with 10 plus years of experience in crafting and working within regulated Quality Management Systems, eliminating waste and improving processes via lean six - sigma, developing new products - design control through 510(k) pre-market approval activities, analyzing data, managing projects across multiple business functions, managing day-to-day operation activities to manufacture medical devices and agricultural goods and services, building teams and managing personnel

TECHNICAL SKILLS

Chemistry: Separations chemistry organic and aqueous; biological electrochemistry; R&D formulations, batch/continuous processes, thermal analysis; Analytical methods GCMS, HPLC, UV/Vis/IR photometer, material properties; fatty acid synthesis; general proficiency across laboratory equipment and techniques

Physics: optics; heat transfer; solar energy PV & thermal; circuits analysis, material properties; mechanics

Mathematics: Statistics significance testing, statistical process control, analysis of sampling plans;

Biology: Amperometric and optical immunoassays, MYRA dynamic

Software: MS Office; Spreadsheets; Databases MS Access, IBM Cognos, Oracle;

Quality Management Systems: EtQ, Website Design, Minitab, AutoCADCross-Functional Lean Six Sigma; Project Management; Risk Management, Failure Modes and Effects Analysis; Robotics & Automation; Machine & Equipment Operation; Construction; Materials

PROFESSIONAL EXPERIENCE

Operations Manager

Confidential

Responsibilities:

Directed day-to-day business operations to make money
Managed multiple projects simultaneously: Applied six sigma DMAIC process and lean tools, maintained budgets, managed conflict, delivered workable resolutions under deadlines
Adapted Quality Management System standards from the Medical Device industry for application within Agricultural industries (ex: document control, risk management, NC, CAPA, Process Capability)
Managed personnel: recruited and trained laborers and tradesmen, developed performance metrics, upheld systems of accountability and discipline, empowered personal growth
Managed risk: purchased variety of insurance products; participated in USDA farm risk programs; developed safety training programs; diversified income streams to include non-farm categories

Sr. Statistician

Confidential

Responsibilities:

Post-market surveillance: Analyzed customer complaints across multiple data sources
Determined appropriate statistical tests, designed sampling plans, defined acceptance criteria
Corrective Action Preventative Action (CAPA)-incident and effectiveness reports

Quality Engineer

Confidential

Responsibilities:

Post-market surveillance: Composed documents per 21.CFR.822 to establish the policy
Detected and assessed potential product quality and safety signals across many data sources
Planned and composed Investigation Decision Reports
Prepared presentations for managers, directors, and executives, communicating policy and analytics
Operations Intern (2004): preventative maintenance systems development
Audit support: performed gap assessments against 21.CFR.820 with internal auditors to ensure readiness ahead of FDA inspections, Located and delivered documents requested by FDA inspectors

R&D Chemist

Confidential

Responsibilities:

Charter project eliminated $3.4M waste, 24-month cost accounted
Created new glucose test strip designs and formulated electronically mediated enzyme catalyzed amperometry assay solutions
Developed temperature compensation algorithms: developed, and executed chemical interferents studies and wrote reports for 510k inclusion
Planned, wrote, and executed product performance validation and verification ( IQ/OQ/PQ ) protocols and analyzed data and wrote IQ OQ PQ reports for use in 510K submissions
Defended study design and reacted to FDA responses and negotiated follow up activities
Managed production of pilot scale batches for use in regulatory submission studies
Simplified SOP’s and evaluated routine QC activities, and revised procedure documents
Designed procedures to accept incoming supplier materials: documentation, resource appropriate quality testing, balanced acceptance criteria, treatment of Nonconforming (NC) materials
Evaluated customer returns: Discovered root cause of defects, detected production issues, and wrote reports to support or oppose customer compensation

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