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Senior Quality Engineer Job

Remote Eligible: 
Onsite Locations(s): 

Maple Grove, MN, US, 55311

Additional Locations: 

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

Senior Quality Engineer - EUMDR

 

About this role:

Provide Quality Engineering support to Maple Grove commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives.  Partner with production and manufacturing engineers for daily operations support, and with product development teams to ensure development of robust new products.  This position will also serve as a project lead to transition risk management deliverables for meeting the new European Union Medical Device Regulations.

 

Your responsibilities will include:

  • Develop and updating risk management deliverables
  • Perform process validation and verification activities and review related documentation
  • Lead or participate in projects to identify root cause and implement corrective and preventive actions.
  • Responsible for understanding nonconformance scope, implementing product stops, and determining release criteria.  Responsible for investigating nonconformances and writing required documentation.
  • Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation to reduce/eliminate the cause of defects.
  • Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
  • Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system.

 

What we’re looking for in you:

Minimum qualifications:

  • BS with 5+ years of relevant experience
  • Good written and verbal communication skills.
  • Must be able to work independently under limited supervision
  • Knowledge of basic Quality Systems and good documentation practices

 

Preferred qualifications

  • Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, material science) disciplines
  • Knowledge of bonding/welding processes and plastic component characteristics
  • Experience in medical device field in a manufacturing support role a plus
  • Self-starter with the ability to identify improvement opportunities
  • Experience leading cross-functional teams and driving projects to completion
  • Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
  • Knowledge of analytical techniques, problem solving and statistical analysis
  • Comfort speaking to groups of individuals.  Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences
  • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
  • Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
  • Bachelor’s Degree with engineering or science major

 

Requisition ID: 495190

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Quality, Healthcare

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