Senior Quality Systems Engineer

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• Bachelor’s degree
• Minimum of 5 years of related work experience
• Demonstrated problem solving skills, preferably in the CAPA process
• Proficient in use of Excel & PowerPoint

PREFERRED QUALIFICATIONS:

• Ability to understand procedural requirements and evaluate documents to ensure compliance to all applicable regulations and requirements
• Strong verbal and written communication, project management, and organizational skills
• Ability to influence and indirectly lead including in challenging situations
• Data analytics skills
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
  Requisition ID: 579139
  Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
  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 prohibited substance 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.
  Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
  Nearest Major Market: Minneapolis
  Job Segment: Senior Quality Engineer, Systems Engineer, CAPA, QA, Quality Assurance, Engineering, Management, Quality, Technolog

• Understand BSC’s Quality System and Quality Systems Management Process.
• Develop, maintain and trend Quality metrics supporting CE Service business.
• Own Quality metrics review process(es) related to CE.
• Support audits related to Capital Equipment.
• Manage process based CAPAs/VIPs to address nonconformances and improvements.
• Trend CAPAs and NCEPs in CE Service process.
• Provide mentoring for other owners of NCEP and CAPA related to CE Service.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Key participant in Capital Equipment communities, to actively collaborate with the company’s strategy of making Capital Equipment a competitive advantage for BSC.
• Partnering with Capital Equipment Service process stakeholders to ensure compliance to BSC Quality System requirements and external regulations for Capital Equipment.
• Partner with CE Process SMEs to interpret laws, regulations, standards and guidance and drive improvements and/or clarifications in BSC Quality System.
• Support and lead improvement projects to sustain Best4 Quality Strategy, ensuring Best Culture, Best Agility, Best Performance and Best Compliance.
• Requires strong engagement with distribution and commercial region teams to understand business requirements and help set up or improve existing Quality System processes to support the business.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
• Contribute actively to relevant internal BSC global Communities of Practice.
• Work across the globe with flexible working hours to support BSC teams across the globe.