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Quality Manager Job

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Date: Oct 1, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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, Post Market Surveillance is a is a seasoned, experienced professional with wide-ranging experience and expertise in Design Assurance, Post Market Surveillance and/or Clinical Risk Management; responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, and Design Controls associated with the sustaining life cycle; specifically Post Market Surveillance Reporting requirements.  Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. 

 

Reviews, analyzes and reports on quality discrepancies related to assembly, process and product function systems and develops disposition and corrective actions for recurring discrepancies.  Interfaces with cross-functional teams including manufacturing, design assurance, engineering, customer, vendor and subcontractor representatives to determine responsibilities, expectations, and solutions.  May serve as liaison between the company and the various governmental agencies. 

 

This role specifically will serve as lead liaison with the MedSurg (Endoscopy and Urology Divisions of Boston Scientific) Team in the execution of Post Market Surveillance Reporting to ensure compliance to EU MDR and country specific regulation(s).  

 

The role will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC and industry level to ensure MedSurg (Urology, Pelvic Health, and Endoscopy) products meet evolving standards in the European Union (EU). Responsible for identifying and helping with implementing continuous improvements to improve product performance and the post market support processes.  

 

Lead team of quality engineers, directly and indirectly in the execution of Post Market Reporting assessments (Periodic Safety Updates) including but not limited to all associated design control and quality system deliverables related with execution.  The role identifies, analyzes, investigates, monitors and documents trends at a product performance levels for post marketing surveillance data as part of the EU MDR reporting requirements.  This role is the leader for interfacing with and answering questions from notified bodies and will be responsible for initiating and executing on continuous improvement activities related to Post Market Surveillance, Product Performance, and the associated quality system. 

 

Your responsibilities include:
Technical Excellence: 

  • Lead Post Market Surveillance activities for the division(s) including but not limited to Post Market Surveillance Plan & Report (PSUR), Clinical Evaluation Reporting evaluation and integration with Risk Management Deliverables, Post Market Clinical Follow-up Plan and Report, Summary of Safety and Clinical Performance (SSCP), and associate Design/Process & Risk Changes.  
  • Documenting data reviews, trend analysis, escalations and actions as an output in formal regulatory submission report (PSUR) for Notified Body review and agreement.
  • Provides guidance and approval regarding quality strategies and approaches at a product, franchise or divisional level. Guides the successful completion of major programs and function in a project leadership role.  Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. 
  • Lead the execution of Quality Deliverables though successful implementation of Design Controls as it related to Product Performance, understanding cascade to all associated product development process elements including but not limited to Design & Development Plan, Specification Development and Verification Strategies, Field Assessment Plan, Test Methods, Design Change, Labeling, Clinical Reporting and Design & Usability Validation Plans; whether internal, co-developed or externally manufactured.
  • Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
  • Lead the execution of the Risk Management deliverables within your teams to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
  • Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution.  
  • Support internal and external regulatory audits as divisional/product and project representative including but not limited to front audit facing roles with government officials and notified bodies accordingly.  
  • Serves as Subject Matter Expert (SME) for all audits across all divisional locations (including manufacturing plants) for the Post Market Surveillance Planning & Reporting process and associated inputs/outputs; including lead support for regulatory submissions.  
  • Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

Quality System Champion:

  • Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources focusing on quality implementation strategy.  
  • Act as division representative on cross-divisional projects defining the quality system(s). 
  • Provides technical leadership to business units. Advise management on potential improvements or enhancement to quality systems and processes in the company. 
  • Support development, implementation and training of corporate quality initiatives.   
  • Owns Quality Plans and Project Plans that support overall product compliance and conformance with external regulations and standards. 
  • Lead generation and adherence to related quality system metrics and performance indicators.

 

People/Program Management Excellence: 

  • Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff.
  • Assists in and/or completes the development of budgets and monitors spending.    
  • Assists in identifying and developing department tools.
  • Assists in and/or determines appropriate staff levels, schedules and resources.  Works with project managers to understand priorities and plan resource and time allocation accordingly.
  • Maintains and enhances cross-functional team relationships.    
  • Works cross-functionally in identifying and resolving and implementing solutions to technical issues.
  • Works cross-divisionally and within the broader organization on procedural and process updates, strategy and works as liaison with division for successful implementation. 
  • Monitors and evaluates project and department progress and results.
  • Represents the organization as the prime technical contact on contracts and projects.  Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. 
  • Uses diplomacy and tact to resolve difficult situations and promotes Boston Scientific values.

 

What we are looking for in you:

  • BS in Mechanical, Electrical, Biomedical Engineering, Scientific or other related degree
  • Minimum of 8 years of Medical Device experience; Design Assurance, Quality Engineering, Quality Systems, Post Market, or equivalent 
  • Strong communication (verbal and written) and presentation skills. Capable of leading complex planning, brainstorming, Kaizen and similar sessions related to process and/or product improvement. 
  • In depth familiarity with the medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, EU MDR and EN 62366.
  • Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent). 
  • Travel approximately 10-15% of the time

 

Preferred Qualifications:

  • MS degree
  • 10+ years of medical device engineering experience 
  • Supervisory experience 
  • Post Market Surveillance Reporting and Clinical Risk Experience 
  • In depth experience with standards assessment and quality planning 
     

 

 

Requisition ID: 503116

 

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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