Quality Assurance Director Career Research and Resources
Emergo Group Consultants
Develop and implement quality systems to meet FDA and ISO requirements, prepare 510(k) submissions and Technical Files for clients
Avg. Salary: $70,000 · Company Rank: 3.0 out of 5
Witt Biomedical Corporation
Developed and implemented comprehensive Quality System to meet FDA/ISO requirements; Interface with FDA during inspections and ISO representatives during audits. Successfully resolved FDA warning letter issue. Prepared 510(k) submissions and prepared International submissions to Canada, Japan, PRC, Taiwan, Australia, Korea, Malaysia to enable expansion to International markets.
Avg. Salary: $70,000 · Company Rank: 4.0 out of 5
MDI Consultants, Inc
Started West Coast office for companyDeveloped and implemented quality systems to meet FDA and ISO 9001 requirements. Provided thrid party certification to FDA in response Consent Decree. Prepared over 10 510(k) submissions.
Avg. Salary: $70,000 · Company Rank: 3.0 out of 5
Siemens Pacesetter, Inc
Implemented internal Audit program, Coordinated efforts to work out from under Consent Decree. Interacted with FDA Investigators during inspections and ISO auditors during audits.
Avg. Salary: $70,000 · Company Rank: 3.0 out of 5
Intermedics, Inc
Implement and manage Quality System. Implemented ISO 9001 system (1st pacemaker company certified to ISO). Coordinated regulatory activity to move to new manufacturing facility. Coordinated MDR and Product Vigilance reporting. Implemented and managed recall activity. Coordinated Engineering Change Board.
Avg. Salary: $70,000 · Company Rank: 5.0 out of 5
Coulter Electronics
Expanded and Managed Quality audit function. Coordinated complaint investigations (reduced backlog of complaints by 90%)
Avg. Salary: $70,000 · Company Rank: 3.0 out of 5
Cordis Corporation
Conduct internal audits, Interface with FDA during inspections. Responded to FDA findings. Prepared and presented reports to Board of Directors each Quarter.
Avg. Salary: $70,000 · Company Rank: 5.0 out of 5
Meditect, Inc.
Developed and implemented Quality System. Resolved supplier quality issues resulting in over $100k in savings. Implemented solvent recovery system resulting in over $150K in savings. Prepared and submitted initial 510(k) submissions.
Avg. Salary: $70,000 · Company Rank: 4.0 out of 5
United States Food & Drug Administration
Conduct inspections at food, drug, medical device companies.
Avg. Salary: $70,000 · Company Rank: 4.0 out of 5
Crest Rehabilitation
Provide oversight to facilities using contract therapy to include billing, quality of service and accuracy of documentation Development of Policy and Procedures for new start-up in house rehab department in long term care facility Make recommendations regarding staffing and hiring
Avg. Salary: $78,000 · Company Rank: 5.0 out of 5
