Senior Quality Engineer

Additional Location(s): Netherlands-Kerkrade

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:
As a Senior Quality Engineer supporting our global Distribution Product Controls, you will play a critical role in advancing Boston Scientific’s commitment to quality and patient safety. This position serves as a quality representative to drive visibility, awareness, and communication around quality initiatives that support departmental, functional, site, divisional, and corporate goals. You will collaborate across global teams to provide quality engineering support for quality system improvements, regulatory readiness, and operational excellence. In addition to leading system and process improvements, this role will mentor junior quality professionals and help ensure compliance with internal and external requirements. This is a highly visible role with significant cross-functional and cross-regional impact.

Work model, sponsorship, relocation:

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

Your responsibilities will include:
• Investigating, identifying, and implementing best-in-class quality engineering practices to support strategic objectives
• Identifying and improving quality systems and processes that support the launch and ongoing distribution of products in compliance with quality and regulatory requirements
• Leading the implementation of assurance activities, process controls, and CAPA systems designed to meet or exceed internal and external standards
• Applying systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
• Advising leadership on enhancements to quality systems, processes, and procedures across the organization
• Solving a range of problems of moderate to high complexity using both existing and novel solutions, balancing business and compliance priorities
• Working independently while receiving guidance on complex or unprecedented issues
• Communicating complex information clearly to cross-functional teams and influencing decision-making
• Participating regularly in cross-functional meetings and presenting key messages logically and effectively

Qualifications:

Required qualifications:
• Bachelor’s degree
• Minimum of 5 years' experience in the medical device or pharmaceutical industry
• Minimum of 2 years' experience in a Quality Systems or Quality Assurance role
• In-depth understanding of Quality Management System requirements, including 21 CFR Part 820 and ISO 13485
• Conceptual, practical, and functional knowledge of quality principles, with a general understanding of related job functions
• Strong technical writing and documentation skills
• Project management experience
• Fluent in English

Preferred qualifications:
• Experience in a regulatory, supply chain, or distribution center environment
• Experience using data analytics tools such as Power BI, Tableau, or similar
• Familiarity with SAP or similar ERP systems
• Proven ability to influence without authority in a matrixed organization

#LI-Hybrid

Requisition ID: 615265 

Minimum Salary: $ 86600 

Maximum Salary: $ 164500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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 test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.