Engineer II, Quality

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:
The Quality Engineer II serves as a quality representative who improves awareness, visibility and the communication of quality initiatives in support of functional, departmental, site, divisional and corporate quality goals and priorities.  This role is responsible for providing quality-based input to support manufacturing, operations and distribution activities, while leveraging extensive technical knowledge and experience across multiple product and production platforms.  The incumbent will develop, establish and maintain quality engineering methodologies, systems and practices to meet company, customer and regulatory requirements.    
 
Your responsibilities will include:

• Supporting specific production areas in achieving required quality standards; provide guidance to quality inspectors and technicians as needed 
• Leading and supporting cross-functional teams in identifying root causes and implementing corrective and preventative actions (CAPA) to control and reduce manufacturing process defects (scrap, nonconforming material, customer complaints); may be responsible for creating risk analyses and FMEAs
• Initiating and leading nonconforming events and CAPA projects; support internal and external regulatory audits
• Collecting and analyzing process defect data to support product and process improvement efforts; apply problem-solving methodologies to identify, prioritize, communicate and resolve quality issues
• Gathering and analyzing quality metric data to enhance sustaining product design and new product development; support site and divisional projects to ensure product introductions, processes and related changes meet regulatory requirements
• Assessing design and process changes to determine the impact on patient care and compliance to quality system requirements; own risk management documentation for assigned processes
• Leading continuous improvement projects and identifying best practices 

 
Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related engineering discipline
• Minimum of 3yrs of technical experience in the medical device or pharmaceutical industry
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 with ability to understand other medical device regulations and standards
• Experience with nonconforming material, CAPA methodologies and related systems
• Experience working in cross-functional teams and driving projects to completion

Preferred Qualifications:

• Certified Six Sigma Green Belt (CSSGB)
• ASQ Certified Quality Engineer (CQE) or Biomedical Auditor (CBA)
• Project management experience with strong presentation and facilitation skills
• Working knowledge of analytical techniques and statistical analysis
• Proficient with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
• Ability to work independently and collaborate with cross-functional teams to complete projects 
• Strong interpersonal skills, with ability to communicate effectively with individuals on all levels
• Strong critical thinking and analytical skills: process and results-oriented
• Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively
   

Requisition ID: 558423

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.

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.