Senior Quality Systems Engineer

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 85.000 - 162.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Zusammenfassung

Boston Scientific Corporation seeks a Senior Quality Systems Engineer for Material Controls to improve awareness, visibility and communication on quality initiatives and objectives. The role supports supplier quality controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.

The position follows a hybrid work model, requiring in-office presence at least three days per week, with relocation and visa sponsorship not offered.

Qualifikationen

• Bachelor's degree with 5 years related experience or Master's degree with 3 years related experience.
• Experience in medical device manufacturing, quality or regulatory/compliance environment.
• 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.
• Degrees in Science or Engineering (preferred).
• 5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems (preferred).
• Training/certifications in ISO 13485 and FDA QSR (21 CFR Part 820) (preferred).

Aufgaben

• Leadership of cross functional projects teams.
• 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 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.
• Guidance on 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.

Kenntnisse

Cross-functional leadership

Project management

Communication

Technical writing

Ausbildung

Bachelor's degree

Master's degree

Tools

Regulatory standards (21 CFR Part 820, ISO 13485)

Jobbeschreibung

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Additional Location(s):US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At 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 time

Your Responsibilities Will Include :

• Leadership of cross functional projects teams
  • 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

Required Qualifications:

• 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

Preferred Qualifications

• 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)

Minimum Salary:$85000

Maximum Salary: $161500

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 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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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.

Nearest Major Market: Minneapolis
Job Segment: Medical Device Engineer, Senior Quality Engineer, Systems Engineer, Quality Engineer, Compliance, Engineering, Legal