Principal Quality Systems Engineer - Supplier QA 603035
Principal Quality Systems Engineer - Supplier QA 603035
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Job Description
Recruiter: Spencer Gregory Hale
Principal Quality Systems Engineer Supplier QA
About This Role:
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 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 Were Looking For In You:
Minimum Qualifications
- Bachelors 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
- Project management skills
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) see 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 nonexempt (hourly) nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm 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 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 identify gender expression veteran status age mental or physical disability genetic information or any other protected class.
Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safetysensitive positions. This role is deemed safetysensitive 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.
Required Experience:
Staff IC
Employment Type
Full Time
