Quality Manager Career Research and Resources
BodyMedia, Inc.
Reviewed and revised existing quality system administrative procedures to better comply with ISO 13485:2003. Assisted in the roll out of the new design control process. Monitored performance of outsourced manufacturing organizations. Engaged ISO registrar. Reviewed and monitored customer complaints and led efforts for CAPA when trends were identified. Led effort to ensure materials were biocompatiable by interacting with ...
Avg. Salary: $85,000 · Company Rank: 4.0 out of 5
ThermoFisher Scientific, Inc.
Maintained and improved the current quality system to maintain compliance with ISO 9001: 2000 and FDA QSR requirements. Revised quality system administrative procedures. Directly interacted with the Field Service and Instrument Technical Support Manager to monitor customer complaints and product returns. Interacted with Consumable Technical Support personnel to monitor customer complaints and identify trends requiring CAPA...
Avg. Salary: $85,000 · Company Rank: 3.0 out of 5
Instrumentation Industries, Inc.
Responsible for upgrading and then maintaining the quality system from ISO 13485: 1996 to ISO 13485: 2003 while still complying with all FDA QSR and Canadian MDR regulations. Revised several quality system administrative procedures including the Quality System Manual. Performed internal audits and led effort to implement any required CAPA. Participated in weekly production status meetings. Developed, monitored and repor...
Avg. Salary: $85,000 · Company Rank: 3.0 out of 5
ImmunoSite, Inc.
Create and implement a quality system to meet CLIA 1988, Commonwealth of PA and College of American Pathologist (CAP) accrediation requirements. Created quality system administrative procedures, and laboratory procedures with the assistance of laboratory staff. Implemented laboratory personnel training and competency assessment program. Implemented internal laboratory proficiency program. Reviewed, monitored client issue...
Avg. Salary: $85,000 · Company Rank: 3.0 out of 5
Amersham Pharmacia Biotech, Inc.
Managed daily operations of two chemists, two moleular biologists, one buyer/planner and one administrative assistant. Provided support to three R&D staff. Reported to the Manufacturing Director of the Amersham production site in Cleveland and participated in weekly production status meetings. After being given the directive to develop a quality system to meet ISO 9002: 1994 requirements under the guidance of the QA Manag...
Avg. Salary: $85,000 · Company Rank: 4.0 out of 5
University of Pittsburgh Medical Center Immunological Monitoring Laboratory
Originally team member involved in re-integration activities. Physically assisted in move back to IML. Continued to maintain ImmunoSite quality sysem separately from IML quality system. Then started to engage in IML quality system by reviewing procedures, performing internal audits and addressing necessary CAPAs. Maintained ImmunoSite client relationships and acted as point of contact for ImmunoSite client study coordinat...
Avg. Salary: $85,000 · Company Rank: 3.0 out of 5
Cellomics, inc.
Responsible for developing an instrument and reagent production group. Iniitated a small volume reagent manufacturing system hand on and wilh help on one staff member. Drafted first round of reagent manufacturing procedures. Initiated development of instrument manufacturing department that also had one staff member. Provided hands on assitance with first instruments that were produced.
Avg. Salary: $85,000 · Company Rank: Not Available
Cellomics, inc.
Undertake the development of a quality system infrastructure meant to eventually meet ISO 9001: 2000, CE marking and CSA requirements. Created several quality system administrative procedures. Actively worked to develop, document and implement processes for product design and development. Acted as QA representative on design teams and attended design review meetings, providing input from a quality perspective. Managed 2 ...
Avg. Salary: $85,000 · Company Rank: Not Available
Cellomics, inc.
Managed all quality control activities for both fluorescent microscopy based instrumentation and reagent manufacturing including supervision of QC staff. Managed the following daily activities for 2 reagent QC staff: 1) performance of raw material and component testing, 2) in process testing, and 3) final functional testing of reagent kits to ensure that all testing met or exceeded established specifications. Reagent QC s...
Avg. Salary: $85,000 · Company Rank: 3.0 out of 5
Paraxel consulting co.
Providing external oversight of operation on production floor for aseptic operations: Four facilities totaling eight (8) production lines-three (3) shifts, seven (7) days a week. Provide real- time support to production, quality, maintenance and engineering activities that may impact sterility assurance. Serve not only in an oversight role but also a mentor/coaching role. Consultant providing full quality support to client...
Avg. Salary: $95,000 · Company Rank: Not Available
