Senior Quality Systems Engineer

Boston Scientific; Arden Hills (MN); Hybride; USD 85 000 - 162 000; Plein temps

Résumé du poste

Boston Scientific is seeking a Senior Quality Systems Engineer for material controls to bolster quality initiatives across global sites. You will lead cross-functional projects, drive CAPAs, and ensure compliance with FDA 21 CFR Part 820 and ISO 13485, while aligning with global sourcing.

The role requires 25% travel and a strong background in supplier quality and regulatory environments. The position is hybrid, based in Arden Hills, MN, with opportunities to influence process ownership, audits,

Qualifications

• Bachelor's degree with 5+ years of related experience or Master's with 3+ years.
• Experience in medical device manufacturing, quality, or regulatory/compliance.
• Knowledge of 21 CFR Part 820 and ISO 13485.
• Willingness to travel 25%.

Responsabilités

• Lead cross-functional project teams and coordinate activities.
• Drive continuous improvement and global alignment.
• Influence across Global Sourcing to achieve outcomes.
• Assess Material Controls processes for FDA/ISO compliance.
• Own CAPAs and participate in Communities of Practice.
• Guide supplier audit/AVL, material qualification, procurement and change control.
• Track material controls metrics and trends.

Connaissances

Project management

Technical writing

Cross-functional leadership

Communication

Process improvement

Formation

Bachelor's degree in Engineering

Master's degree

Description du poste

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About This Role: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.Work Mode: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.Relocation Assistance:Relocation assistance is not available for this position at this time.Visa Sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this timeYour Responsibilities Will Include:Leadership of cross functional projects teamsUsing project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelinesDriving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirementsCommunicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomesProviding 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 RequirementsOwnership of highly visible, global, systemic CAPAs while leading through a Community of PracticeProviding 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 processesDetermining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global processParticipates 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 projectsRequired Qualifications:Minimum of a Bachelor's degree with 5 years of related experience or minimum of a Masters degree with 3 years of related experienceMedical device manufacturing, quality or regulatory/compliance environmentPrevious experience in a Supplier Quality, Supplier Engineering, or Sourcing organizationUnderstanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485Must be willing to travel 25% of the timeTechnical writing and documentation skillsPreferred QualificationsDegree(s) in Science or Engineering5+ years of experience in Supplier Quality, Supplier Management, or Quality SystemsTraining/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)Project management skillsRequisition ID: 636156Minimum Salary: $ 85000Maximum Salary: $ 161500The 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 transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.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.