Peter Malik Email & Phone Number

Cleveland, Oh, Us

Elyria, Ohio, United States

Elyria, Ohio, United States

Elyria

Supervise the daily operations of the Quality Lab. Assist Quality Technicians when necessary. Perform various testing activities. Review and approve test results performed by Quality Technicians.Perform internal ISO and TL audits. Review current work instructions and revise as needed. Responsible for investigating identified nonconforming material in order to determine the root cause of the failure.Fill-in for Quality Technicians and Quality Manager when necessary.Conduct the Quality portion of the new employee orientation.Conduct and document weekly/monthly/annual calibration verifications. Identify when new measuring instruments need to be purchased.Collaborate with the various departments within the plant to resolve Quality issues.Prepare customer certifications.Improved the method of filing and identifying records, hastening the retrieval of archived records.Conduct training within the Quality department.Manage the various equipment program setups and create SOP’s instructing others on how to run the equipment.Employee of The Month; October 2018.

Perform both prospective and retrospective software/spreadsheet validations. - Evaluate and determine risk values for software and spreadsheets. - Prepare validations including IQ, PQ and OQ. - Worked with a team in the execution of validations. - Maintain database of software/spreadsheets that require validation and the results.Development, education, and utilization of IQS Quality Management Software. - Collaborating with other departments to develop customizations. - Supervise employees during development of software. - Facilitate education on use of software. - Provide training opportunities for groups to learn utilization of the software. Assist IT in trouble shooting various computer related issues throughout the company.Maintain internally developed Microsoft Access databases used in returned goods and customer complaint process, nonconforming material, CAPA management and record retention.Present regular updates to upper management on progress of IQS Management software development and software/spreadsheet validations.Managed control room of 4-5 people for document and data retrieval functions during ISO and FDA audits. - Ensured that properly requested documents were obtained from various departments. - Reviewed obtained documents for accuracy. - Provided documents to auditors/investigators in a timely manner. - Maintained record of documents provided. - Participated in close out meetings.

Westlake, Ohio

Acted as backup for Quality Supervisors and CAPA Manager.Utilized written quality procedures and other documentation as required for effective administration of the Corrective and Preventive Action (CAPA) System.Worked with various departments within the company to investigate customer complaints and evaluate returned products by utilizing various forms of root cause determination methods such as 5-Whys and 8D.Generated responses to customers communicating results of investigationsDocument investigations to provide data to upper management, while maintaining internally developed Microsoft Access databases used to store the data.Investigate nonconformances to which formal Corrective and Preventive Actions (CAPA) have been issued and to facilitate the activity to closure.Review Nonconforming Material Reports (NMR) to determine the need for corrective action and write new corrective action plans or update existing plans as needed.Review for adequacy Supplier Corrective Action Requests (SCAR).Made recommendations for improvements to inspection plans and procedures based on results of root cause investigations from customer complaints and nonconforming material.Control and maintain quality records applicable to these functions.Provided inputs to upper management to support effective trending and reporting activities in accordance with ISO standards and FDA regulations.Provided trending data from various databases to design engineering for product improvements.Created Management Review presentation for Vice President of Quality and Regulatory.Addressed any IT issues within my scope to manage.

Performed document control functions, such as processing quality procedural changes and developed quality procedures in the required format. Developed a database utilizing Microsoft Access. - This facilitated quicker access for data retrieval.

Software Programing

Began studies in computer maintenance and software programing.

High School Diploma