Jackie Jaskula

VP QA/RA

Natera

Aug 2022 - Current (4 years 3 months)

Sr. Director Quality

Natera

Oct 2021 - Aug 2022 (11 months)

Regulatory Manager

OrthoPediatrics

May 2018 - Oct 2021 (3 years 6 months)

Director Quality/Regulatory Affairs

OriGen Biomedical

Aug 2015 - May 2018 (2 years 10 months)

Directly responsible for compliance to medical device standards and regulations in US, Europe, Brazil, and Canada and partnering with distributors for compliance in other geographies. Compliance includes maintenance of quality system infrastructure, creating and maintaining submissions for authorization to market where required, managing product compliance throughout the product lifecycle, conducting post-market surveillance activities, managing requirements for regulatory reporting in the case of adverse events. Participate in design control activities, including risk management. Additionally, responsible for implementing product inspection requirements (incoming, in process, and final device), ensuring effective implementation of inter

Sr. Quality Assurance Manager

Life Technologies Thermo Fisher

Jul 2013 - Jun 2015 (2 years)

As the Sr. QA/QC Manager, I'm responsible for oversight of the quality management system in compliance with ISO 9001, ISO 13485, FDA requirements for general purpose reagents, and USDA regulations for animal health products.

As a site leader, I am responsible for ensuring the quality system and Quality Assurance personnel meet business needs and that business process comply with requirements of standards and regulations.

As a people manager, I am responsible for ensuring that my direct reports support compliance to the quality system, work in harmony with our business partners, and support our customers requirements. Additionally, I develop my direct reports and other stakeholders in compliance. Direct reports are fur

Quality Director

Agilent

Mar 2010 - Jun 2013 (3 years 4 months)

I became part of Agilent Technologies when Agilent acquired Stratagene. I began working at Stratagene in Nov. 1998.
Responsible for quality control/assurance organizations at 3 U.S. sites; medical device and product regulatory affairs for analyte specific reagents and research use only products. Ensure compliance to ISO 9001, ISO 13485, 21 CFR Part 820. Implemented and maintained design control process for medical device design. Develop strategy and objectives for quality organization to ensure success of the business in the area of general laboratory and in vitro diagnostic applications utilizing bioreagents, hardware, and software products. Team lead for project to bring Texas manufacturing activities in compliance with Quality

Quality Manager

Agilent Technologies

Jan 2007 - Mar 2010 (3 years 3 months)

Responsible for quality control/assurance organizations at 3 U.S. sites; medical device and product regulatory affairs for analyte specific reagents and research use only products. Ensure compliance to ISO 13485, 21 CFR Part 820. Implemented and maintain design control process for medical device design. Develop strategy and objectives for quality organization to ensure success of the business in the area of general laboratory and in vitro diagnostic applications utilizing bioreagents, hardware, and software products. Team lead for project to bring Texas manufacturing activities in compliance with Quality System Regulations for sale of analyte specific reagents and in vitro diagnostic products.

S

Sr. QC Manager

Stratagene

Oct 2005 - Jun 2007 (1 year 9 months)

In this position, I was responsible for inspection of incoming hardware parts (off the shelf and custom), inspection of production materials, lead the corrective/preventive action process, lead control of nonconforming materials process, provide support to resolve customer complaints, coordinate internal and supplier audits, maintain the ISO 13485-compliant quality system, represent the quality system to external auditors, maintain control of documents and QC records, administer validation review board.

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QC Manager

Ambion

Jan 1995 - Jan 1998 (3 years 1 month)

Coordinate laboratory quality control testing of products used in in RNA-based research; support customer complaint investigations; interface with R&D for transfer of new products to manufacturing.

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Jackie Jaskula

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Behavioral traits