At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Job Function
Incumbent serves as main divisional point of contact for global Operations Compliance Oversight:
• Instrument refurbishment – creation, edit, and maintenance of the refurbishment procedures and monthly financial reporting on business profitability • Instrument refresh – creation, edit, and maintenance of the refresh procedures and governance on when to do both • Spare part repair – edit and oversight for all repair procedures worldwide • Third party and Abbott facility instrument reprocessing – contract negotiation, facility capacity and efficiency evaluations, compliance and quality performance, refurbishment standard setting, and part sourcing • Local sourcing – creation, edit, and oversight of requirements, training, compliance, and process function • Spare part inventory and usage levels – creation and implementation of inventory control strategies, and cost targets, • Spare part logistics – creation and implementation of logistics strategies to reduce cost, improve customer service, and lower inventory • Census accuracy issues – provide guidance and analysis for true census data and resolve discrepancies between CMS, finance, and inventory census data • Asset utilization metrics – creation of utilization reports, monthly/quarterly reporting, provision of utilization and throughput analyses to affiliates and areas • Product retirement – census management, scrap timing control, reconciliation of missing assets
Incumbent to ensure undertaken activities are focused towards economic profitability improvement; raising customer loyalty; lower service support costs; employee engagement and delivering value based pricing.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Global Asset Management:
Serves as main divisional point of contact for global instrument refurbishment and spare part repair; third party reprocessing; local sourcing;
spare part inventory levels; or census accuracy issues.
Takes a leadership position in establishing cost improvement; methods configuration; and service goals. Assumes primary responsibility for identifying; selecting and delivering projects in support of these goals. Provides global leadership for service facility compliance objectives and training.
Conducts annual inspections of global reprocessing sites. (Mexico, Brazil, Italy, S. Korea, and China) Responsible for the standardization of procedures and determines and issues certification of global reprocessing sites.
Serves as subject matter expert to all organizations within ADD.
Ensure clean audit outcomes from refurb/repair centers.
Creates an organizational consensus and implements proactive approaches for managing global service costs. Identifies potential problem areas and implements corrective actions.
Defines; creates and supports standards and processes for global Reprocessing Operations in the areas of documentation creation; release;
control; compliance; ESD; and configuration management.
Develops division level guidance documents that govern international compliance and product definition. Develops and implements strategies to improve global census accuracy.
Responsible for the redistribution of global assets to maximize global utilization.
Oversees the contracts for all third party instrument or spare part reprocessing providers.
Position Accountability / Scope:
The incumbent reports directly to the Global Service with indirect reporting relationships to the Divisional Vice; Global Quality Assurance.
It is expected that this individual will work with division management from; Commercial area; Affiliates; Manufacturing Operations; Product Development; Finance; IT; Commercial Operations; and QA/RA to ensure that inventory initiatives; global refurbishing; and service design improvements result in direct and auditable business improvements.
Authority to Act:
This position has total accountability for managing and integrating strategies; processes; and resources in support of Global Asset Management; and Global Service Support. This position is guided by broad objectives and subject to review only on a periodic basis by site and division management to assure consistency with division/corporate direction.
Minimum Bachelor's degree (B. S.). or minimum 10 years direct technical (engineering or service) experience with Abbott products.
Minimum Experience/Training Required:
Knowledge of regulations and standards affecting IVDs and Biologics. Technical
- Combined minimum 15 years related experience in medical manufacturing operations, service, and quality with at least 10 years at Abbott.
- Strong understanding of process control, verification and validation, service techniques; reliability statistics, and alternate sourcing.
- 2-5 years in Operations Compliance Oversight
- In depth knowledge of compliance, statistical methods, and project management.
- Able to translate theoretical methodologies into practical applied practices within ADD processes with the ability to explain these practices to technical and non-technical personnel.
- Strong problem solving background.
- Actively facilitate and/or lead continuous improvement teams, with sound negotiation and problem solving skills.
- Able to drive the effective use of statistical problem solving and quality tools through leadership, consulting and training.
- Execution of Lean Manufacturing and Service concepts and principles, SPC, FMEA, DOE, and advanced statistics.
- Understands Abbott and ADD's Quality Systems, especially Design Control, CAPA, Production & Process Control and Supplier
- Understands Global Service IT Processes and Tools
- Good business acumen
- Experience in FDA/cGMP/QSR, ISO 9001/ISO13485 and CE Marking.
- Knowledgeable of company's strategies and change philosophies.
- Basic foundation in the requirements of cost accounting and strategic planning
- Ability to manage without direct authority
- Ability to influence decisions and compel action in a complex organization.
United States > Irving : LC-02
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
We are a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Our products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. Our comprehensive line of products encircles life itself - addressing important health needs from infancy to the gold...en years.
Abbott has sales, manufacturing, research and development, and distribution facilities around the world, close to where our customers need us to be. We are recognized for our global reach and our ability to serve our customers around the world.