Senior Quality Systems Engineer
About The Position
This Senior Quality Systems engineer will be part of the Global Quality Systems Team supporting the Headquarters site. Focus areas include supporting the improvement initiatives related to the Quality Management Review process and Signals Review meeting forum. This role will also support analysis of internal and external data to identify trends, signals and metrics that may be useful to drive improved decision making in both of these forums. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary. This role acts as the representative to improve awareness, visibility, and communication on global initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Partner with functional teams across all divisions to drive and improve processes. 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.
Requirements
- Bachelor’s degree in science and/or engineering and 6+ years medical device/Quality System experience or Master’s degree and 4+ years of medical device/Quality System experience.
- Proficiency with Excel, pivot tables and data analysis.
- Demonstrated competency working cross functionally and globally.
- Strong communication and presentation skills.
- Ability to develop effective, positive interpersonal relationships.
- Proficiency with Microsoft Office suite, including SharePoint.
Nice To Haves
- Bachelors degree in engineering or equivalent experience
- Experience using Power BI
- Experience with regulations, including EU MDR, 21 CFR 820, MDSAP program and ISO 13485.
- Experience with NCEPs and CAPAs (non-conforming events and the corrective action process).
- Driven, energetic, self-assured professional with high personal integrity
- Experience updating, writing and implementing quality system procedures
- Familiarity with BSC systems such as Windchill, eCAPA
Responsibilities
- Supporting the organization’s improvement activities related to the Quality Management Review process and the quarterly Signals Review meetings.
- Review and trend internal and external data to identify signals, trends and other useful information that supports decision making.
- 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.
- Lead or support projects within the Quality System Management team.
- Own NCEP and CAPA records as applicable to the role.
- Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.
- Support internal and external audits on an as needed basis.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
