Senior Quality Systems Engineer

Boston Scientific•Arden Hills, MN

2d•$85,000 - $161,500•Hybrid

About The Position

The Senior Quality Systems Engineer of material controls will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support the Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements. 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.

Requirements

Minimum of a Bachelor's degree with 5 years of related experience or minimum of a Masters degree with 3 years of related experience
Medical device manufacturing, quality or regulatory/compliance environment
Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization
Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
Must be willing to travel 25% of the time
Technical writing and documentation skills

Nice To Haves

Degree(s) in Science or Engineering
5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems
Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
Project management skills

Responsibilities

Leadership of cross functional projects team
Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines
Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements
Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes
Providing continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Medical Device Requirements
Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice
Providing guidance to functional members and teams on in area of process ownership, such as supplier audit/AVL, material qualification, procurement, supplier change and corrective action through audit support and CAPA processes
Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process
Participates or leads in appropriate BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning.
Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects

Benefits

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
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).
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.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.
Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.
Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.
As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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.