Quality Systems Engineer II

Recruiter: Spencer Gregory Hale

Quality Systems Engineer II

About the role:

As a Quality System Engineer II, you will serve as a key Quality representative for the Maple Grove Management Controls and Quality Planning Processes.  This role supports the coordination, execution, and continuous improvement of Quality Management Review with a focus on Divisional activities and reports.  In this highly visible role, you will work with Site and Divisional Quality Leadership and engage cross-functionally to prepare quarterly Quality Management Review presentations and compliance reports, maintain Delegation Memos, and complete records to support the compliance of the Quality System Management process for Maple Grove.  

Work model, sponsorship, relocation:

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. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Provide customer-centric support to Site and Divisional Leadership, including Managers, Directors, and Vice Presidents, to ensure the compliance of Management Control records with internal and external requirements
• Schedule Divisional Quality Management Review meetings with leadership and applicable stakeholders
• Prepare and disseminate Management Review Presentation Templates in preparation for meetings
• Coordinate the completion of Management Review content with Quality Leadership and Subject Matter Experts
• Assist with facilitation of Divisional and Site Management Review meetings
• Maintain Delegation Memos for Maple Grove Site and Divisional leadership
• Assist with completion of quarterly 302 reports to support SOX compliance
• Complete and file records related to Management Controls, including Quality Goals & Objectives and Quality Management Review
• Drive Quality System Management initiatives and continuous improvement projects
• Support Site Audit Excellence and Audit Readiness activities

Qualifications:

Required qualifications:

• Bachelor's degree
• Minimum of 2 years' experience in the medical device or pharmaceutical industry
• Skilled in Microsoft Office Applications, including Power Point, TEAMS, and Excel
• Multitasks, prioritizes and meets deadlines in a timely manner
• Strong presentation skills with the ability to schedule and facilitate large meetings
• Highly detail-oriented with strong analytical skills

Preferred qualifications:

• Excellent verbal and written communication skills
• Ability to collaborate and communicate effectively across all levels of the organization
• Demonstrated ability to work independently or lead in a team setting
• Continuous improvement and growth mindset with a desire to expand Quality Management System knowledge
• Proven ability to influence without authority in a matrixed environment
• Strong networking skills to build and maintain effective partnerships

Requisition ID: 620341 

Minimum Salary: $ 69500 

Maximum Salary: $ 132000 

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.