Senior Quality Systems Engineer
Boston Scientific · Arden Hills, MN
- Level
- Senior
- Team
- Quality
- Travel
- 25%
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Medical devices
- Posted
- 9 days ago
The role in 30 seconds
A senior quality role at Boston Scientific (medical devices) in Arden Hills, MN. Specifically, this role will support the Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.
- They ask for
- 5+ years · degree required
- Tools it names
- CAPA, ISO 13485, FDA / GMP, Supplier quality
- Day to day
- about 25% travel · relocation help
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At a glance
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- 1
Pick 2–3 people on the Quality team at Boston Scientific
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- 2
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- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
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- The posting says about 25% travel. Between which sites?
- How did you land the job? What stood out in your interviews?
- 4
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About the role
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)
- ✓Project management skills
Minimum Salary: $ 85000
Maximum Salary: $ 161500
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 .
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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
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
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