Max Baumgartner Email & Phone Number

Warsaw, Indiana, United States

Warsaw, Indiana, Us

- Responsible for collaborating, leading, coordinating, directing, and managing activities relating to planning, strategy, tracking and communication of the necessary tasks and responsibilities in relation to gas plasma sterilization process validations for terminally sterilized implantable medical devices.- Work effectively/productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. - Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet in relation to gas plasma sterilization to implement Zimmer Biomet quality goals by supporting process improvements and cost saving initiatives. - Responsible for managing microbiology sterilization associates as it relates to sterilization validation projects for the Warsaw, IN business unit.- Exercised knowledge of and ability to use industry standards including, but not limited to GMP, QSR, USP, ANSI/AAMI/ISO Environmental & Sterilization standards as related to medical devices, sterilization, contamination control and validation activities.- ISO/FDIS 22441 working group ST-WG16 – Vaporized Hydrogen Peroxide primary team member.

Raynham, Ma, Us

- Responsible for collaborating, leading, coordinating, directing, and managing activities relating to planning, strategy, tracking and communication of the necessary tasks and responsibilities in relation to Joint Reconstruction and Powertools sterilization validation of products, processes, operations, or services.- Primary Sterility Assurance lead for Powertools division for both operations and new product development.- Responsible for conducting project validations and studies to support sterilization process control, implant cleanliness, product sterilization, sterility assurance, and contamination control. - Primary core team member for Joint Reconstruction and Powertool New Product Development (NPD) projects with respect to hazard identification, risk management, and design recommendations from the perspective of cleanability and sterilization of new medical device implants, sterilization cases, and reusable surgical instruments.- Collaborated with contract laboratories and conducted reusable instrument case validations, including cycle development, heat distribution, lethality, and durability with respect to steam sterilization to meet customer Instructions for Use (IFU) requirements per ISO 17664.- Reusable device design specialist with respect to cleanability, disinfection, & sterilization.- Performed gamma dose substantiation and dose mapping sterilization validations for terminally implantable medical devices.- Provided corporate global support for various sterilization activities which include gamma irradiation, ethylene oxide and steam sterilization modalities.- Routinely led supplier audits for the purposes of due diligence acquisitions and compliance to international sterilization standards and company policy requirements. - Exercised knowledge and ability to use industry standards including, but not limited to GMP, QSR, USP, ANSI/AAMI/ISO Environmental & Sterilization standards.

Warsaw, Indiana, Us

- Responsible for leading, coordinating, directing and managing the activities, as it relates to: planning, strategy, tracking and communication of the necessary tasks and responsibilities in relation to transfers of products, processes, operations, or services between manufacturing sites. - Primary responsibilities include reviewing all production transfer plans globally for regulatory compliance to ensure acceptance criteria have been met.- Responsible for global tracking and monitoring of all transfer plans to completion.- Responsible for monthly update to upper management regarding tracking and monitoring of transfer plans globally. - Responsible for managing Transfer Quality Engineers as it relates to the transfer projects in the Americas business unit.- Responsible for the global implementation and training of the corporate transfer procedure.

Warsaw, Indiana, Us

- Responsible for ensuring supplier compliance, pursuant to federal, international and corporate regulatory and quality requirements and ensuring Biomet corporate-wide compliance with regulatory requirements for purchasing controls.- Primary responsibilities include implantable raw material supplier and global supplier qualification and management. Performing QMS and material process checklist audits associated with these suppliers ensuring compliance to 21 QSR Part 820 and ISO 13485. - Responsible for global supplier quality monitoring which includes global supplier scorecards and global SCAR management.- Perform corporate compliance audits as necessary.

Vevey, Ch

- Responsible for Sanitation, Allergen Management, GMP’s, Pest Control, and Hygienic Zoning- Responsible for conducting Clean In Place & Clean Out of Place validations for all process lines. - Duties and responsibilities continue to develop as position evolves.

Warsaw, Indiana, Us

- Responsible for conducting project validations and studies to support process control, implant cleanliness, biologic upgrade, product sterilization, sterility assurance, and contamination control. - Primary core team member for all Warsaw Knee New Product Development (NPD) projects with respect to hazard identification, risk management, and design recommendations from the perspective of cleanability and sterilization of new medical device implants, sterilization cases, and reusable surgical instruments.- Performed STERRAD® 100 & 200 Gas Plasma Sterilization process validations for terminally implantable medical devices.- Performed steam sterilization annual requalification activities for steam sterilization autoclaves, which include heat penetration distribution, temperature mapping, and microbial challenge studies. - Conducted reusable instrument case validations, including cycle development, heat distribution, lethality, and durability with respect to steam sterilization.- Performed sterile product release of terminally implantable medical devices for distribution.- Reusable device design specialist with respect to cleanability & sterilization.- Performed gamma sterilization validations for terminally implantable medical devices.- Provided corporate global support for various sterilization activities which include gamma irradiation, gas plasma, steam, & dry heat.- Participated in Kaizen 5S lean manufacturing activities.- Exercised knowledge of and ability to use industry standards including, but not limited to GMP, QSR, USP, ANSI/AAMI/ISO Environmental & Sterilization standards as related to medical devices, sterilization, contamination control and validation activities.

Abbott Park, Illinois, Us

- Worked in Quality Assurance laboratory providing testing results for approved products in industry.- Testing products with extensive laboratory equipment and skill, recording and releasing data ensuring limited bacterial and pathogenic growth.- Worked under strict Pharmaceutical and FDA regulations providing safe approved products.- Developed experience using complex instrumentation such as Celsis, BAX, Mini-Vidas, Tecra Assay detecting organisms such as Salmonella, Staphlococcus, and E. coli.- Continuous environmental monitoring of plant water system on incoming and outgoing supply for superior health and product performance for plant employees and Ross Products consumers.- ELISA testing experience for hypoalergenic and immunodeficient products such as Elecare and Alimentum using Western Blot and Electrophoresis.- Microbiological testing of incoming raw materials, in-process and finished product samples to ensure limited pathogenic growth for premium products.- Preparing media and reagents used for laboratory testing purposes.

Bachelor Of Science Agriculture

Began Master'S Degree, Orthopaedic Regulatory & Clinical Affairs