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Pathology Quality Manager Job

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Date: Nov 27, 2021

Location: Alpharetta, GA, United States, 30009

Company: Boston Scientific

Additional Locations: US-GA-Alpharetta; US-GA-Atlanta


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


About the role: 

Quality Manager I is responsible for leading the anatomic pathology quality program , leading a team of Quality Engineers, Specialists and Technicians in direct support of the Boston Scientific Pathology Laboratory. The Quality Manager is a key partner to the Laboratory Operations and Laboratory Support function teams in achieving Patient Care, Quality System Regulations, Customer Satisfaction and Business Goals. 


Purpose Statement 

Develops and maintains quality policies and controls to ensure that Pathology Laboratory meets a high standard of quality patient care, continuous improvement and customer satisfaction. Monitors changes to accreditation regulations, laboratory performance for trends and customer feedback.  Manages Laboratory Quality Management System and ensures compliance with all applicable regulation and standards.  May serve as liaison between Boston Scientific Pathology and the various accreditation agencies. Partners closely with the Medical Director, and leaders from functional areas: Laboratory Operations, Customer Success, Revenue Cycle Management, Laboratory Information Systems and other departments on identifying, supporting and executing continuous improvement ideas.  


Your responsibilities will include: 

  • Ensures compliance and ongoing accreditation with applicable accreditation agencies (CAP, CLEP, CLIA, State Agencies, ISO) 
  • Develops quality monitoring metrics that foster continual quality improvement and customer satisfaction as part of an overall Quality Management System 
  • Develops and implements quality strategies; seeks innovative approaches to attaining quality goals. 
  • Demonstrates knowledge of the appropriate rule and regulations while applying them in complex situations. 
  • Develops department budget and monitors spending. 
  • Determines appropriate staff levels and schedules.  Works with key partners to understand priorities and plans resource allocation accordingly. 
  • Participates in the development and maintenance of a company culture characterized by highly motivated employees with clear understanding of their roles, a willingness to embrace quality issues and a strong focus on patient care and customer satisfaction 
  • Enhances employee development, training, and compliance with laboratory standards 
  • Maintains and enhances collaboration through cross-functional team relationships and effective communication with the Medical Director, Leadership and all levels of pathology employees 
  • Provides guidance, training and assists direct staff in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff. 
  • Lead a team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and drive best practices throughout the organization. 
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. 
  • Problem Solving/ Complexity of work: Identifies issues, gathers facts to resolve technical and operational problems.  
  • Monitor and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs, and/or operations. 
  • Monitor and ensure compliance with company policies and procedures (e.g.  accreditation/regulatory requirements). 


What we're looking for in you:

Required Qualifications

  • Bachelor's degree in Biology, Chemistry or related field plus 5+ years of related work experience in Medical Laboratories 
  • ASCP Certification  
  • 3+ years of direct supervisory leadership experience with people development 
  • Continuous Improvement and Laboratory Technical background, 3+ years Laboratory Quality Management System experience in a regulated industry   
  • Previous experience managing external audits, (CAP, CLEP, CLIA and ISO15189) 
  • Six Sigma Green Belt certification or equivalent Problem-Solving methodology experience 


Preferred Qualifications

  • 4-year engineering degree preferred with a passion for continuous improvement 
  • Six Sigma Black Belt certification 
  • Master’s degree in business, healthcare management or related technical field 
  • Previous experience implementing ISO 15189 requirements 


Quality System Requirements

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. 
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System. 


Requisition ID: 507360


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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