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Quality Engineer II-Design Assurance Job

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Date: Sep 11, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Location: Marlborough, Massachusetts (US-MA), United States (US)
Additional Locations: (n/a)
Hiring Manager: Michelle Pham Frankfort
Recruiter: Camden Hayden Pyle

 

Quality Engineer II—Design Assurance
 
About the role:

Primary focus of this role will be the execution of design control deliverables associated with design file remediation and sustaining projects to meet European Union Medical Device Regulation (MDR) requirements. This position interfaces with cross functional teams to complete sustaining projects, design control deliverables, and activities to ensure MedSurg (Urology, Pelvic Health, and Endoscopy) products meet evolving standards in the European Union (EU). 
This role ultimately provides quality engineering support to sustaining and improving current products on market, as well as new product development.  Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical development projects, continuous improvement product development projects, sustaining existing product families, or system/services support.
 
Your responsibilities include:

⦁    Identifies and implements effective risk management and process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. Specifically, in relation to achieving and continuity compliance to the EU MDR regulation. 
⦁    Lead the implementation of assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements.
⦁    Act as team member in supporting quality disciplines, decisions, and practices.
⦁    Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
⦁    Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues.
⦁    Advise management on potential improvements or enhancement to quality systems and processes in the company.
⦁    Act as key team member to the EU MDR transition team in updating and bringing Design History Files to state-of-the-art readiness including risk management and Post Market Surveillance activities. 
⦁    Create Complaint Review Reports to support conformance to EN ISO 62366:2015 Usability
 
What we’re looking for in you:

⦁    Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering.  
⦁    Minimum of 3 years of Medical Device design controls and risk management experience required.
⦁    In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.
⦁    Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
⦁    Strong communication (oral and written) and presentation skills.
⦁    Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).

 

Preferred Qualifications:
⦁    MS degree preferred
⦁    Familiarity with the EU MDR Regulation
⦁    Expertise with Quality Planning and standards gap assessment 
⦁    Focus on detailed work with emphasis on accuracy and completeness 
⦁    Excellent organizational and planning skills; drives for results 
⦁    High energy problem solver capable of driving items to closure
 

 

Requisition ID: 487924


Nearest Major Market: Boston

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