Quality Systems Engineer II
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
