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Senior Quality Assurance Specialist Job

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Date: Nov 4, 2021

Location: Warsaw, Poland

Company: Boston Scientific

Additional Locations:

 

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.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

 

Currently we are looking for a

 

Senior Quality Assurance Specialist 

 

 

Purpose of this role is to serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Collaborates with Quality management to recommend, design and implement functional process improvements. Senior QA Specialist develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements, provides compliance guidance and support for technical development concepts, regulatory, operational, or systems/services, may mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate. 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. 

 

Key Responsibilities:

 

  • Implementing, maintaining and improving the Global Quality System
  • Maintain, control, revise and update the Document Management System in accordance with applicable Quality System Standards
  • Support and prepare for site level internal/external audits and act as Subject Matter Expert (SME) in audits
  • Provide functional support as an SME as applicable to internal & external functions
  • Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/ manage improvement projects within the organization; (VIP, QMP, Star, Lean, 5S)
  • Demonstrate leadership and seniority in Quality Assurance aspects
  • Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Lead the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
  • Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes
  • Executes the testing and training development for future roll-outs of business applications
  • Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with Global Quality System
  • Drives awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific

 

Qualifications:

  • 5+ years’ relevant experience
  • Experience in Quality Systems Management, System Compliance and Audit
  • Practice in Project Execution 
  • Knowledge of Quality Standards ISO 13485:2016 and ISO 9001:2015
  • Bachelor’s Degree or equivalent
  • Fluency in English 

 

We offer:

Our company offers full time job in an international environment with attractive benefits package, competitive salary and a permanent employment contract. We also offer trainings and development tailored to employee’s needs.

 

Requisition ID: 508183

 

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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