Sr Quality Systems Engineer

Recruiter: Spencer Gregory Hale

Sr Quality Systems Engineer      

About the role:  

This Senior Quality Systems engineer will be part of the Global Quality Systems Team. This role will be part of the Corporate Audit Support team and serve as the primary contact to support Russian audits, as well as other audits during heavy audit periods within the year. Audits will be spread across the BSC network and will require management of preparation activities as well as support and direction related to audit follow up and non-conformance responses. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary, such as leading new or revised large scale regulatory requirements that span across BSC sites and/or Quality System functions.

Your responsibilities include:

• Primary support for Russian audits including activities such as:
• Project management of audit readiness deliverables, audit scheduling and coordination across multiple sites, suppliers and business units.
• Interface with Global Quality process and sub-process owners, site quality leads, cross-functional subject matter experts to ensure audit readiness across the organization.
• Support audits and engage Quality System process and sub-process owners when needed, including coordinating audit requests across the BSC network.
• Assist with coordination and management of audit follow up questions, actions, and non-conformance responses within expected timeframes.
• Audit support may require assistance off hours or overnight.
• 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 projects within or that support the Quality System Management team.
• Own NCEP and CAPA records as applicable to the role.

What we’re looking for in you:

Minimal Qualifications:

• Bachelor’s degree in science and/or engineering and 5 to 8 years medical device/Quality System experience or Master’s degree and 3 to 5 years of medical device/Quality System experience.
• Strong project management skills: ability to develop a project plan and manage a project through execution with minimal oversight
• Experience with audit support, including planning and preparation.
• Experience with NCEPs and CAPAs (non-conforming events and the corrective action process).
• Ability to adjust work hours to accommodate a global audit schedule that spans time zones.
• 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.
• Proficiency with Microsoft Office suite, including SharePoint.

Preferred Qualifications

• Bachelors degree in engineering or equivalent experience
• Audit experience (front room / back room / auditing) 
• Driven, energetic, self-assured professional with high personal integrity
• Experience writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA
• Russian fluency is a plus.

Requisition ID: 600099 

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 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 identify, 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.