Principal Quality Systems Engineer - Supplier QA

Boston Scientific Gruppe; Marlborough (MA); On-site; USD 103,000 - 197,000; Full time

Job summary

An established industry player is seeking a Principal Quality Systems Engineer to enhance quality initiatives and compliance in supplier management. This role involves leading cross-functional teams, ensuring adherence to medical device regulations, and driving continuous improvement in material controls processes. You will own global CAPAs and provide guidance on quality system requirements. If you have a strong background in quality assurance within the medical device sector and a passion for improving processes, this opportunity offers a chance to make a significant impact in a collaborative environment.

Qualifications

• 5+ years in medical device quality or regulatory environments.
• Experience in Supplier Quality or Supplier Engineering.

Responsibilities

• Lead cross-functional project teams to meet quality goals.
• Ensure compliance with FDA regulations and ISO 13485.

Skills

Quality System Requirements Understanding

Technical Writing Skills

Project Management

Continuous Improvement

Supplier Quality Management

Education

Bachelor's Degree

Master's Degree

Job description

Principal Quality Systems Engineer - Supplier QA

Onsite Location(s): Marlborough, MA, US, 01752

Recruiter: Spencer Gregory Hale

About This Role: The Principal 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.

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

What We’re Looking For In You:

Minimum Qualifications:

• Bachelor's degree and 5+ years or Masters degree and 3+ years of experience in a 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 10% 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)

Requisition ID: 603035

Minimum Salary: $103700

Maximum Salary: $197000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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.

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.