Quality Systems Engineer II

 Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills

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 Systems Engineer II will be part of the Global Quality Systems Team. This role will serve as a backup for Corporate Audit Support during heavy audit periods within the year. This includes supporting audits across the BSC network and assisting with planning and preparation for Corporate Headquarters audits. In addition, this individual will be responsible for supporting the process owner for activities related to the Regulatory Requirements process, assisting with monthly Quality System Governance Board meeting preparation and execution, and supporting the process owner with the Standards Management process. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary. 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Backup to the Corporate Audit Support function on an as needed basis, including, but not limited to:
• Supporting site audits 
• Coordinating audit requests across the BSC network
• Planning, preparation, and execution of Corporate Headquarters audits 
• Present and participate in External Audit Community of Practice 
• Assisting off hours 
• Maintaining external audit documentation/SharePoint site as needed
• Work with the owner of the Regulatory Requirements and Standards Management processes to assist with tasks, such as monitoring status of open or ongoing assessments.
• Work with the process owner/facilitator of the Quality System Governance Board to assist with meeting preparation, execution and deliverables.
• Interface with Global Quality process and sub-process owners, site quality leads, cross-functional subject matter experts to ensure audit readiness across the organization.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise on potential improvements or enhancement to quality systems and processes in the company.
• Drive project work within Quality System Management team. 

Required Qualifications

• Bachelor’s degree in science and/or engineering and 3+ years medical device/quality system experience or Bachelor’s degree and 5+ years of medical device/quality system experience.
• Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR. 
• Proficiency with Microsoft Office suite, including SharePoint.
• Ability to travel up to 10%

Preferred Qualifications

• Bachelors degree in engineering or equivalent experience
• Applies continuous improvement principles in the development of the quality system
• Strong communication and presentation skills
• Ability to work independently with minimal oversight 
• Ability to develop effective, positive interpersonal relationships
• Ability to adjust work hours to accommodate a global audit schedule that spans time zones
• Experience with audit support
• Audit experience (front room / back room / auditing)  
• Driven, energetic, self-assured professional with high personal integrity
• Ability to coordinate and lead groups of people towards a common goal
• Data visualization and presentation
• Experience writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA
   

Requisition ID: 598166

The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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.