Senior Quality Systems Engineer

Additional Location(s):  N/A

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 Senior Quality Systems Engineer (CAPA Lead) will be primarily responsible for supporting the Global Capital Equipment (GCE) CAPA team and serve as a CAPA Lead for the GCE CAPA portfolio. In this role, primary responsibilities include CAPA project management, mentoring, training, data trending, and metric reporting.

 

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.

 

 

 

Your responsibilities will include:

• Support Global CE CAPA and NCEP activities as a SME, owner, project manager and/or trainer
• Track and trend CAPA and NCEP related information and report at various review boards to a broad audience
• Champion quality and compliance to quality requirements throughout the NCEP and CAPA process
• Responsible for ensuring timely implementation of projects within the GCE Quality Assurance organization, including continuous improvement projects
• Responsibility to identify and escalate NCEP/CAPA areas in need of improvement, identify improvements, and track progress through metrics
• Apply sound, systematic problem-solving methodologies to ensure robust solutions that resolve quality issues
• Contribute actively to internal BSC global Communities of Practice

 

Required qualifications:

• Bachelor’s degree in relevant field and 5+ years CAPA/NCEP or equivalent experience
• Minimum of 5 years of related work experience, preferably in the medical device industry, or an equivalent combination of education and work experience
• Technical aptitude and demonstrated problem solving skills in the CAPA process

 

 

Preferred qualifications:

• Previous CAPA ownership
• Can use, teach and improve standardized tools
• Ability to influence the effectiveness of each phase of the CAPA project indirectly lead, including in challenging situations
• Strong verbal and written communication, and organizational skills
• Strong networking skills to foster collaborative relationships
• Ability to communicate effectively with all levels of the organization
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements

 

 

Requisition ID: 623768 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

 

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-ter