Mark Heiser Email & Phone Number

Chicago, IL, US

San Jose, California, US

Responsible for all Operations, Engineering and Maintenance activities spanning over 90 Swiss platform CNC machines.

San Francisco, CA, US

• Recruited to remediate site quality system comprising multiple 483s spanning over two FDA inspections, numerous aging complaints and CAPAs while in parallel direct routine daily business to remain compliant within ISO.
• As site PMO drove over 50 individual 483 commitments to closure over a 7-month period, avoiding a warning letter initiation.
• Managed deployment of complaint handling system from paper based to ETQ Reliance, migrating legacy data and overall integration activities within 5 months.
• Established new CAPA program by improving structure around coordination, task management, root cause analysis and review board fundamentals as part of 483 commitment around CAPA timeliness and effectiveness.
• Successfully led migration of 21 CAPAs and 180 NCs in paper-based format into Agile, assuring all necessary information mapped accurately for improved tracking and metrics reporting opportunities.

Washington, D.C., US

• Direct all activities at 3 Contract Manufacturers regarding component, in process and final device quality. Manage supplier quality program for Asia encompassing over 200 unique suppliers, assuring all meet.
• Achieved $36M annual tariff savings by launching SMT production in Vietnam site, verifying facility and all product quality requirements were met prior to mass production release and maintaining 99.5% quality yields.
• Organized over 150 process document submissions from 2 Contract Manufacturers as part of FDA Remote Regulatory Assessment, a component of the company's submission for market approval.
• Coordinated ~500k annual forecasted new product release assuring inspection plans, process validations, in process and end of line quality documentation was released within schedule.

Washington, D.C., US

• Directed operations of manufacturing products supporting a multi-billion dollar medically-regulated company, including high-speed automated equipment connected to class 8 cleanrooms. Accountable for all functional.
• Increased capacity 200% by relocating multi-billion dollar production facility to new brownfield location while maintaining exemplary quality and meeting aggressive production schedules.
• Attained 750k unit per day capacity via 6 high-speed production line installations and validations within a 10 month period.
• Produced a 40 point average OEE improvement per line by strengthening downtime tracking, streamlining changeovers, and implementing technology improvements.
• Realized $4M annual savings through optimizing headcounts and by implementing continuous improvement projects stemming from time studies and work content analysis, highlighting under-utilized operators and improved.
• Orchestrated a 37% equipment utilization improvement by way of process improvement surrounding forecast optimization and production line enhancements. Aligned training efforts for technicians and engineers to better.

• Manager of privately-held contract manufacturer involving SMT (Surface Mount Technology), through-hole, and box builds. In charge of manufacturing, quality, engineering, facilities, supply chain, and purchasing.
• Increased production capacity 150% by re-locating within 24 months a multi-million dollar manufacturing facility in Mexico to a new greenfield location.
• Boosted productivity 30% to support double-digit organic and new business growth opportunities by streamlining logistics processes and improving talent retention.
• Reduced inventory spend $2.5M by increasing VMI (Vendor-Managed Inventory) program 5x to leverage suppliers for improved inventory coverage.

Meridian, Idaho, US

• Directed production of custom hearing aid instruments, accessories, and earmolds delivered to over five global distribution hubs utilizing a team of 450 employees. Governed under ISO 13485 and FDA class I/II medical.
• Lifted manufacturing efficiencies 25% and reduced re-work 50% by leading the US-China offshoring project, moving all remaining custom hearing aid production from Canada and US facilities to central China facility.
• Accelerated machine availability 40% in support of projected sales growth by coordinating and overseeing two production space build-outs. In parallel identified, planned, and implemented an offsite space to house.
• Passed facility’s first-ever FDA audit by aligning critical resources from global sites, ensuring all necessary documentation was in order and accurate.

Chicago, Illinois, US

• Oversaw operations in US and Canada, having responsibility of 2 facilities producing and distributing Beltone-branded custom hearing products. GN Resound is the parent company of Beltone.
• Achieved $1.5M savings by leading plant consolidation of Canada into US facilities, leaving service-related activities for support of Health Canada requirements.
• Completed 2 FDA and 5 ISO 9001/13485 audits as a Class I and II medical device manufacturer by collaborating with the quality team in amending the quality system including QSP, complaint handling, and CAPA systems.
• Reduced inventory levels 25% by returning excess & obsolete items and maximizing throughput by leveraging redundant parts across assemblies.

Chicago, Illinois, US

• Managed team of 150 staff producing custom hearing aids with emphasis in optimizing throughput, embracing new industry technologies, and transferring to new ERP system.
• Boosted productivity 30% with limited hiring and training burden by implementing “mini flow lines” that increased efficiency and better operator utilization.
• Implemented a $1M technology process upgrade involving 3D printing technology for assembly of key parts resulting in increased throughput and lower internal remake metrics.
• Consolidated 2 fully independent quality systems for better transparency by ensuring local operational quality regulations were included and clearly defined.

Chicago, Illinois, US

• Site manager for manufacturing plant consolidation from Chicago to Minneapolis. Coordinated training and production needs both locally and abroad, minimizing customer impact.
• Gained 50% efficiency by reducing manufacturing footprint 40%, consolidating 3 product specific production lines into 2 as consolidations and transfers were ongoing.
• Managed stable KPI metrics (returns, remakes, turn around time, hours per unit) via successful transition of knowledge to consolidated location.
• Achieved 2 ISO 13485 re-certifications by improving documentation handling, archiving, tracking customer complaints, enhancing operator training requirements and process validations.

Chicago, Illinois, US

• Managed custom production line where efficiency tracking, capacity planning, training, recertification, and equipment preparedness were included.
• Increased operator understanding of processes by streamlining work instructions and TQCs that enhanced their ability to deliver quality products in a timely manner.
• Lowered final device functionality testing time 30% by introducing a quality incentive program, aimed at improving final testing yield for better product reliability.

Washington, DC, US

Building Maintenance Supervisor, Great Lakes, IL (2000 - 2002)Managed a 50,000 square foot training facility involving preventive and corrective maintenance, civilian and military vendor negotiations, and grounds upkeep.Classroom Instructor (1997 – 2000)Maintained 95% class average as Electrician's Mate A School classroom instructor, providing education of.

Master Of Science - Ms, Management With Specialization In Organizational Leadership And Change Management

Bachelor Of Science - Bs, Electronics Systems Technologies