Principal Quality Systems Engineer

Recruiter: Spencer Gregory Hale

Principal Quality Systems Engineer

About the role:

This Principal Quality Systems Engineer will be part of the Global Quality Systems team supporting the Headquarters site.

Focus areas include certificate management to ensure BSC remains compliant to EU MDR and other regulations. This role will also support many projects and cross functional teams where Quality System changes are discussed and guidance and direction is requested to ensure conformance to regulations and standards while also allowing for large-scale quality system changes to be implemented. This includes providing direction and support to acquisition teams seeking guidance and decisions related to integration activities that impacts BSC’s certificates. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary.

The Principal Quality Systems Engineer will act as a project manager to create a timeline, deliverables and identification key project leads to drive at completion of complex audit responses and non-conformances within the defined timeframe.

They will also collaborate with quality management to recommend, design and implement functional process improvements. Will mentor less experienced quality staff, as well as other cross-functional stakeholders on implementing quality processes and procedures as appropriate.

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.

Your responsibilities will include:

• Key responsibilities include maintaining quality system certificates to site responsibilities, assessing quality system changes for reportability and certificate changes and managing the complexities of BSC’s growth and acquisition integration.
• Manage and oversee critical Notified Body relationships for BSC headquarters, which includes assistance with audit scheduling, audit management, communication of quality system changes and relationship management to ensure a strong partnership between Boston Scientific and the Notified Body.
• Support internal and external audits and audit responses on an as needed basis, as both a subject matter expert and as the liaison for the Notified Body.
• Provide guidance and direction to cross functional teams seeking input on complex Quality System projects and requests, such as implementation of a large scale regulation, site expansion or transfer, etc.
• Lead and project manage internal and external audits and audit responses on an as needed basis.
• Own NCEP and CAPA records as applicable to the role.
• Provides direction, coaching, and mentoring for other team members.
• Proactively investigates, identifies, and implements process improvements, preventive CAPAs and VIPs.
• Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications.
• Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

What we’re looking for in you:

Minimal requirements

• Minimum bachelor’s degree in science and/or engineering  
• 9+ years medical device/quality system experience (or a master’s degree in science and/or engineering and 7+ years of medical device/quality system experience).
• Project management leadership: ability to create and manage a project through execution independently and ability work cross functionally to manage deadlines.
• Strong communication and presentation skills
• Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR.
• Ability to develop effective, positive interpersonal relationships.
• Demonstrated competency working cross functionally and globally. 
• Proficiency with Microsoft Office suite, including SharePoint.

Preferred Qualifications

• Experience with managing and updating notified body certificates.
• Experience working with notified bodies and audit support.
• Driven, energetic, self-assured professional with high personal integrity.
• Experience writing and implementing quality system procedures.

Requisition ID: 615693 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

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.

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.

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.