Senior Quality Engineer

Additional Location(s):Netherlands-Kerkrade

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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 Scientifics 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 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:
Bachelors 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 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) isnt just business its personal. And if youre 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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest 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.