Boston Scientific Quality System Engineer III 

United States, Massachusetts, Marlborough 

452053383

About the role:

The Quality System Engineer III will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support Quality initiatives, ensuring compliance to Medical Device regulations and BSC Quality System requirements with a continuous improvement mindset.

Please note this is a hybrid position (in office minimum three days per week) ideally in Buenos Aires, Argentina, with the flexibility to be located in Marlborough, MA, Galway or Cork, Ireland, Kerkrade, Netherlands or other BSC site. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Communicate and document internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues
• Document and communicate non-conformances, evaluates impact, and makes recommendations for corrective actions
• Supports departmental, functional, divisional, and corporate quality goals and priorities
• Act as team member in supporting quality disciplines, decisions, and practices
• Builds quality into all aspects of work by maintaining compliance to all quality requirements
• Participate in CAPA and Continuous Improvement project teams as appropriate
• Other duties as necessary or required by the department or organization

Required qualifications:

• Bachelor's degree and 4+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organisation
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Project management skills
• Fluent in English language

Preferred qualifications:

• Good knowledge of Microsoft Excel
• Strong communication, presentation, facilitation skills
• Organizational skills with good attention to detail
• Good working knowledge of SAP and non-device software validation would be beneficial

Maximum Salary: $ 151400

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.