Al Beatrez
Plant Manager at Rise Baking Company- Claim this Profile
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Bio
Rachel Yi-Hsuan Su
Al and I are colleagues at Zepto Life Technology, a start-up specializing in developing class II diagnostic medical devices using microfluidic technology and Giant Magnetoresistance (GMR) sensor. The platforms are innovative and complex, but Al has established a large amount of controlled quality system documentation and protocols, and ensures the company is following the FDA QMS and ISO 13485 regulations. Al is also an expert in Design Control. When we worked together to develop a molecular diagnostic platform, he was knowledgeable of the process and led design and risk analysis for different departments at different stages during the product development process. His level of attention to detail really impressed me. We were able to mitigate a lot of risks because of Al's contribution. Al is a true leader in the quality and manufacturing field.
Todd Klein
In my role as an experimental research scientist, I place great value in discussions of experimental design. Especially when the stakes are high, I always want to consult with Al to ensure my experiments stand up to scrutiny and meet the needs of relevant stakeholders. This level of trust is rooted in my respect for the diligence and attention to detail required and expected by Al to excel in quality and manufacturing within the complex and multidisciplinary landscape of the medical device industry. There is no shortcut to attaining the experience and consequent perspective that Al brings to the table on this or the many other aspects of our quality management system and it's requirements. Al is a valued colleague in the quality and manufacturing space.
Rachel Yi-Hsuan Su
Al and I are colleagues at Zepto Life Technology, a start-up specializing in developing class II diagnostic medical devices using microfluidic technology and Giant Magnetoresistance (GMR) sensor. The platforms are innovative and complex, but Al has established a large amount of controlled quality system documentation and protocols, and ensures the company is following the FDA QMS and ISO 13485 regulations. Al is also an expert in Design Control. When we worked together to develop a molecular diagnostic platform, he was knowledgeable of the process and led design and risk analysis for different departments at different stages during the product development process. His level of attention to detail really impressed me. We were able to mitigate a lot of risks because of Al's contribution. Al is a true leader in the quality and manufacturing field.
Todd Klein
In my role as an experimental research scientist, I place great value in discussions of experimental design. Especially when the stakes are high, I always want to consult with Al to ensure my experiments stand up to scrutiny and meet the needs of relevant stakeholders. This level of trust is rooted in my respect for the diligence and attention to detail required and expected by Al to excel in quality and manufacturing within the complex and multidisciplinary landscape of the medical device industry. There is no shortcut to attaining the experience and consequent perspective that Al brings to the table on this or the many other aspects of our quality management system and it's requirements. Al is a valued colleague in the quality and manufacturing space.
Rachel Yi-Hsuan Su
Al and I are colleagues at Zepto Life Technology, a start-up specializing in developing class II diagnostic medical devices using microfluidic technology and Giant Magnetoresistance (GMR) sensor. The platforms are innovative and complex, but Al has established a large amount of controlled quality system documentation and protocols, and ensures the company is following the FDA QMS and ISO 13485 regulations. Al is also an expert in Design Control. When we worked together to develop a molecular diagnostic platform, he was knowledgeable of the process and led design and risk analysis for different departments at different stages during the product development process. His level of attention to detail really impressed me. We were able to mitigate a lot of risks because of Al's contribution. Al is a true leader in the quality and manufacturing field.
Todd Klein
In my role as an experimental research scientist, I place great value in discussions of experimental design. Especially when the stakes are high, I always want to consult with Al to ensure my experiments stand up to scrutiny and meet the needs of relevant stakeholders. This level of trust is rooted in my respect for the diligence and attention to detail required and expected by Al to excel in quality and manufacturing within the complex and multidisciplinary landscape of the medical device industry. There is no shortcut to attaining the experience and consequent perspective that Al brings to the table on this or the many other aspects of our quality management system and it's requirements. Al is a valued colleague in the quality and manufacturing space.
Rachel Yi-Hsuan Su
Al and I are colleagues at Zepto Life Technology, a start-up specializing in developing class II diagnostic medical devices using microfluidic technology and Giant Magnetoresistance (GMR) sensor. The platforms are innovative and complex, but Al has established a large amount of controlled quality system documentation and protocols, and ensures the company is following the FDA QMS and ISO 13485 regulations. Al is also an expert in Design Control. When we worked together to develop a molecular diagnostic platform, he was knowledgeable of the process and led design and risk analysis for different departments at different stages during the product development process. His level of attention to detail really impressed me. We were able to mitigate a lot of risks because of Al's contribution. Al is a true leader in the quality and manufacturing field.
Todd Klein
In my role as an experimental research scientist, I place great value in discussions of experimental design. Especially when the stakes are high, I always want to consult with Al to ensure my experiments stand up to scrutiny and meet the needs of relevant stakeholders. This level of trust is rooted in my respect for the diligence and attention to detail required and expected by Al to excel in quality and manufacturing within the complex and multidisciplinary landscape of the medical device industry. There is no shortcut to attaining the experience and consequent perspective that Al brings to the table on this or the many other aspects of our quality management system and it's requirements. Al is a valued colleague in the quality and manufacturing space.
Credentials
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HACCP for Food Manufacturers
Eurofins Analytical Laboratories, IncMay, 2023- Nov, 2024 -
Scrum Master Certified (SMC)
VMEdu Inc.Apr, 2021- Nov, 2024 -
Certified Professional Project Manager Certification
University of St. Thomas -
Licensed Minister
Universal Life Church and the State of Minnesota -
Licensed Minnesota Realtor
State of Minnesota -
Operational Excellence - Lean Sigma, Lean, and Six Sigma
Medtronic
Experience
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Rise Baking Company
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United States
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Food and Beverage Manufacturing
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300 - 400 Employee
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Plant Manager
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May 2023 - Present
Providing leadership for plant operations at two Minneapolis facilities with overall responsibility for production, maintenance, quality, safety, sanitation and warehousing. Our dedicated creative team produces an unrivaled product portfolio of artisan breads delivering uncompromising quality. Providing leadership for plant operations at two Minneapolis facilities with overall responsibility for production, maintenance, quality, safety, sanitation and warehousing. Our dedicated creative team produces an unrivaled product portfolio of artisan breads delivering uncompromising quality.
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Coloplast
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Denmark
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Operations Manager
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Jul 2021 - Feb 2023
Provided plant leadership and support to manufacture wound and skin care products for people with intimate healthcare needs. • Transformed plant management through the implementation and use of visual management. • Improved employee growth and development through the establishment of a job tier program. • Collaborated to incorporate bottle labeling inline with packaging to reduce inventory and cycle time by 50% while reducing direct labor. • Implemented real-time material issuing to mistake proof material usage and improve inventory. • Established multiple Power BI reports and dashboards to improve business intelligence. • Established a win/win department restructuring by redirecting 30% of the team into new roles offering employee growth while enhancing manufacturing agility. • Incorporated process improvements to reduce hazards and improve efficiency. • Reformatting work orders to improve usability, reduce human errors and improve verifications. Show less
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Higher Dimension Materials Inc.
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St Paul, MN
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VP, Manufacturing and Supply Chain
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Feb 2021 - May 2021
Provided strategic and tactical leadership for the manufacturing of Super Fabric textiles. Drove significant continuous improvement to favorably impact employee safety, quality, customer commitments and productivity. • Improved machine uptime by ~30% by executing equipment prep in parallel to manufacturing. • Audited and addressed multiple OSHA concerns improving employee safety. Identified and eliminated root cause for repeat high cost tooling damage. • Executed 5S and installed new LED lighting to improve the work environment. • Implemented FIFO visual inventory management system to manage and prevent material loss. • Prevented nonconforming production by updating ERP product naming and incorporating critical consumable tooling into the bill of materials. • Established work instructions for each manufacturing line. Show less
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Zepto Life Technology
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United States
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Biotechnology Research
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1 - 100 Employee
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Quality and Manufacturing Leader
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Nov 2018 - Jan 2021
Led the establishment and execution of quality and manufacturing capabilities to support the development and manufacturing of biomolecular sensing systems for the medical device start-up to create a new standard for point of care diagnostics • Established a full quality management system from the ground up. • Executed the establishment of a full suite of quality system procedures and templates. • Provided leadership to identify, select and implement a full electronic quality management system and ERP solution to support all business needs. • Selected, purchased and implemented a learning management system (LMS). • Implemented design for reliability and manufacturability, DFMEA, PFMEA and process mapping. • Established software and process validation master plans and implementation strategies. • Planned and executed ISO 13485 certification. • Purchased and implemented software solutions to aid the design controls and risk management processes. • Led new product development to identify user needs and medical device requirements and execute risk management. • Mentored process owners through IQ/OQ/PQ and executed manufacturing process improvements critical to long-term success. Show less
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AUM Cardiovascular, Inc
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Director Of Quality Assurance
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Mar 2018 - Oct 2018
Provided Management Representation, leadership and execution for all pre/post market quality objectives and processes including design controls, document control, complaint management, NCMR, CAPA, etc. • Identified and executed improvements to the quality management system and design history files. • Coordinated successful internal and external audits by regulatory authorities and distributors. • Drove continuous improvement through supplier management and enhanced supplier controls. • Responsible for manufacturing operations and inventory management; implemented Lean Manufacturing. • Provided program management for product development of an innovative RFID sensor product. Show less
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Medtronic
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. CAPA Program Manager
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2013 - 2017
Provided leadership and project management for complex, technical, cross-functional Quality System CAPAs at the business unit and corporate level on Medical device and registration tracking, Product labeling processes, Calibration, CAPA process, Product integrity non-conformances in distribution, and Quality System implementation within laboratories.• Completed timely investigations identifying root cause and corrective actions using DMAIC.• Established and implemented comprehensive action plans.• Successfully planned and executed multiple business unit CAPA and nonconformance remediation efforts to drive improved regulatory compliance and reduced risk.• Owned and executed the product deviation process to ensure compliance and to maximize outcomes. Show less
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Sr. Program Manager - Corporate Quality
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2010 - 2013
Provided corporate leadership to successfully execute Global Quality improvement projects.• Provided core team leadership to establish a Medtronic Quality Strategy implementation rollout and to execute and influence an improved corporate quality culture. Established sustainability through integrated enterprise quality communications. • Established a corporate quality CAPA board, provided board support and coaching on enterprise CAPAs.• Engaged a cross-business team to significantly revise the corporate process validation policy to ensure compliance to regulations, improve product quality and process efficiency.• Led the execution of Kaizen events to reduce labeling errors and to improve manufacturing yields.• Provided program and project management for CAPA, Manufacturing Quality and Risk Management corporate sub-councils, initiatives and policies. Provided corporate CAPA process owner support.• Provided global manufacturing leadership to complete an enterprise-level process validation remediation effort to ensure regulatory compliance and to improve product and process quality.• Participated in multiple audits and a Medtronic Operating System assessment. Show less
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Corporate Commercial Release Consultant
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2006 - 2010
Provided corporate quality and regulatory risk management oversight, consultation and influence to 5 business units for new product development, OEM initiatives, post acquisition branding, manufacturing transfers, etc.• Addressed issues within BU’s resulting in actions to strengthen quality, compliance and controls.• Interacted with Sr. and Executive Management providing guidance on issues. • Provided leadership for a global enterprise Supplier Quality Purchasing Controls policy revision.• Proposed a strategy to establish corporate-wide quality agreements to greatly improve efficiency/effectiveness; established agreement between Suppliers and Regions.• Led the formation of a corporate-wide “Cost of Poor Quality” metric to support the quality culture.• Analyzed and presented field corrective action data to support Executive strategic planning. Show less
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Sr. Strategic Sourcing Program Manager
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2005 - 2006
Facilitated and led a 20 person cross-functional, cross-divisional team through the decision-making process to successfully select a strategic co-sourcing manufacturer for high volume molded products. Executed financial analysis to identify $800k in cost savings and participated in establishing a supplier contract. Collaborated to successfully implement the competitive outsourcing.
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Sr. Manufacturing Operations Manager
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2000 - 2005
Provided plant management, operations management, strategic planning, performance management and talent development to the Component Operations supporting the manufacture of $68MM in implantable, value-add components with ~20 direct reports and ~350 employees. Ensured employee safety, compliance, product quality, maintenance, inventory control and fulfillment of supply chain requirements.• Managed multiple cost centers and annual operating planning.• Facilitated significant Lean Manufacturing improvements.• Provided project management for facility and operational changes.• Initiated the development and implementation of IT tools to automate training records and to manage development activities.• Initiated the use of Scientific Injection Molding principles resulting in a significant productivity improvement. Show less
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Sr. Engineering Supervisor
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1996 - 2000
Led and managed a 5 person engineering team and a 40 person production department supporting plastic injection molded implantable components, extrusions/catheter shafts and thermoformed products. Drove a vision for proactive, creative process improvements resulting in employee empowerment, accountability and team building.• Initiated, developed internally and implemented a Kanban/visual management business intelligence software application resulting in the transformation of the department through empowerment of employees.• Instrumental in establishing long-range, annual operating and disaster recovery plans • Justified new department positions (Training Coordinator and Business Systems Analyst) and developed personnel for the roles• Performed equipment installations and process qualifications/validations. Show less
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Sr. Manufacturing Engineer
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1994 - 1996
Provided engineering support for the development and production of injection molded implantable components. Results oriented through the use of data, statistical analysis and continuous improvement.• Planned and executed a project to resolve quality issues and ramp-up molded component production volumes by 300% within 6 months resulting in a savings of $400k/yr.• Initiated, developed and implemented a manufacturing assessment process to improve the rigor and reliability in qualifying raw materials. Show less
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Education
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University of St. Thomas - Opus College of Business
MBA, Business Administration - Finance -
University of Minnesota-Duluth
Industrial Technology, BS
Community
