Carol H.

About Carol H.

I am a Quality professional who is self-motivated, dedicated to quality and protecting the customer with more than 30 years’ experience at many levels of manufacturing and corporate management in medical device, aerospace and automotive. I have a proven track record of problem solving. • In my current role as the team lead, I reduced overdue work orders from 1/3 of the annual total to zero in less than 1 year by identifying the underlying conflicts. I also reduced the monthly alarm rate from over 150 per month to less than 10 through identification of environmental impact on the processes. • I reduced overdue calibrations through the reduction of inventory, re-engineering of the department layout and equipment improvements.• I implemented automated inspection systems and changed the culture to make that that new standard.• Established key department metrics and demonstrated improvement.During my career I have: • Managed 18 people across 3 shifts with an annual department budget of $2.1 million.• Developed personnel skills and improved employee impact in the organization by empowering them to make decisions commensurate with their new skills.• Managed and executed supplier audit schedules, issued reports and corrective actions; issued supplier complaints and oversaw improvements; approved ECN and managed supplier product launches.• Worked with high volume/low mix and high mix/low volume manufacturing.• Launched new product including design support, supplier selection and launch, design validation, process validation (IQ/EQ, OQ, PQ) and process monitoring for ongoing control.• Implemented new QMS systems and revised/updated existing QMS to meet the latest requirements across 9 site organizations; completed registration for ISO-13485:2016, AS9100:D, ISO-9001:2015, TS-16949.• Completed remediation projects for regulator driven and internally identified issues.• Purchased and integrated automated CMM inspection systems that became the gold standard for inspection with savings totaling a year in scrap reduction and developed communication techniques for production to correctly interpret the information.I have gained an extensive knowledge of a variety of processes including:• Machining part sizes from micro 3-5mm to 18”+(aluminum, titanium, stainless steel, cobalt chrome, steel) with micron tolerances (gears, lathes, grinding)• Aluminum casting (gravity, squeeze) • Heat treat (oil, salt, water, air quench; steel, aluminum, stainless and cobalt)• Plastic and rubber injection molding• Stamping and fine blanking• Welding

Experience

1. Principle Remediation Quality Engineer

   Medtronic

   Oct 2022 — Present · Irvine, CA, US

Education

• Indiana University South Bend

  Bachelor of Science (BS), Business Administration, Management and Operations

  1980 — 2000