David Z. Email & Phone Number

Waterford Township, Mi, Us

Rochester, Michigan, Us

Fulfill all duties of Management Representative as defined by 21 CFR 820 and ISO 13485.Establishes compliance operational strategies by evaluating trends, setting up critical measurements,accumulating resources, resolving problems, and implementing innovative solutions to improve current ways ofworking.Achieve complete quality compliance management systems in accordance with organization plans andadherence to legislation and agreed regulatory bodies’ processes and procedures..Participate in the Advanced Product Quality Planning process including advising teams and creating relatedFlowcharts and Control Plans.Report to the management team on the wellbeing of the companies’ quality status on both internal processesand external customers and suppliers.Interact and co-operate with all members of the organization, its suppliers, and clients/customers.Consult with all departments on new and existing jobs including providing information on CSV files, CPK studies,PPAP, APQP, gauging, Coordinate Measurement Machine (CMM) reports and programs, Customer ComplaintNumber Log (CCN) and customer concerns.Be available to meet with the customers and suppliers at their locations or facilities that a quality concern ispending.Updates job knowledge by taking part in educational opportunities, reading professional publications, andparticipating in professional events or organizations.Acts on dealing with noncompliance situations, creating realistic plans to overcome them.Oversees the company’s quality audit program related to internal processes and regulatory compliance.Oversees and updates, as needed, the company’s quality risk management system.

Mason, Michigan, Us

Oversee various aspects of the quality management system in compliance with ISO 13485:2016.. Directly oversee the following laboratory programs Sterilization (ISO 11137-2:2015+A1:2023) , Water management (USP<1231>), Medical Device cleanliness ((ISO 19227:2018), and Metallurgical testing (tensile, abrasion, and microstructuring) of Titanium or Hydroxylapatite coatings on titanium, stainless steel, cobalt chrome, and titanium caribide. Other programs participating in or directly over are Training, Document Control and Change Control, to include technical writing for SOP/WI/forms, Quality Data Reviews and Management Reviews, Calibrations (ISO17025:2017):, host external (customer or regulatory body) and internal audits, follows Standard or Regulatory updates, Validation review, and Key performance Indicators. Developed an eQMS (WinSPC) to capture quality data for tracking and trending. Experience in continuous improvement activities to reduce company expenditure resulting in monthly saving of $24,000.

Charlotte, Nc, Us

Boca Raton, Florida, Us

Worked as lab director for a moderately complex laboratory performing chemical testing for total protein and hematocrit.Over saw the Grand Blanc and Westland locations.Performed the approval of procedures within the facilities.

Boca Raton, Florida, Us

As AMQ I work with operations to ensure quailty is built into what we do at the plasma collection center.

Boca Raton, Florida, Us

As Technical Consultant I assist in ensuring staff are CLIA trained and the center is following guidelines set by the CFR for laboratories of moderate complexity testing.

Boca Raton, Florida, Us

Boca Raton, Florida, Us

Full-time commitment to ensuring the quality activities within the center are in effect. Actively track and trend quality related events to determine any risk assessments. Ensure that equipment calibration is properly documented and is with accepted criteria. Continuously look for ways to improve center activities and to ensure quality of product, employee safety, and donor safety. Work with management as part of the leadership team to ensure the center is on track for company goals. Ensure staff are receiving appropriate training and documenting the training within a learning management system.

Boca Raton, Florida, Us

Proper processing, handling, and storage of collected human plasma.

Boca Raton, Florida, Us

To ensure the quality activities within the center are in effect. Actively track and trend quality related events to determine any risk assessments. Ensure that equipment calibration is properly documented and is with accepted criteria. Continuously look for ways to improve center activities and to ensure quality of product, employee safety, and donor safety.Occasionally work within the Production Areas (Reception, Donor Floor, or Processing) to add individual expertise to the area.

Boca Raton, Florida, Us

Proper processing, handling, and storage of collected human plasma.

Tasks designed to assist in the continuous operation of the Quality Control laboratory. Coordinated the ordering and receiving of chemical reagents and reference standards ranging from non-controlled to controlled substances while tracking inventory and consumption. Assisted the QC Metrologist in the standardization and calibration of equipment. Created and revised documents such as procedures, specifications, and methods when required. Assist the Quality Control and Analytical Development groups by preparing solutions for raw material testing, finished product testing, validation, or development. In the event of an out of calibration or out of specification performed the ensuing investigation to define the root cause. In addition to these tasks received training on various types of equipment.

Provide quality assurance testing on the production of liquid and granular sugar using chemical analysis in accordance of HACCP and SQF regulations. Follow current Good Manufacturing Practices set by the FDA. High pace work environment dealing with computers and equipment, phone calls, handling samples of sugar, and reporting results. This position is partially supervised in which there are times where the lab technician operates the entirety of the lab unsupervised.

Plymouth, Mi, Us

Worked as part of a team to provide quality assurance on the production of bottled water; this was done with little to no supervision and required independent judgment of bottled water quality. Performed chemical analysis on water to meet specifications set by HACCP and SQF. Followed current Good Manufacturing Practices set by the FDA. During shift changes attended meetings to convey what has occurred during the shift.