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18000JQ6 Requisition #
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Sr Quality Engineer - CAPA
18000JQ6
Danvers, MA 

Careers That Change Lives    

The Senior Quality Engineer -CAPA will participate in the execution and administration of quality assurance programs, policies, processes, procedures, and controls in compliance with the evolving and complex US and global requirements of the medical device industry. The person is responsible for the execution of CAPA and Continuous Improvement projects and quality system, policies, processes, and procedures. He/she will need to provide expertise and guidance to the business in interpreting and executing against the quality system elements to ensure compliance. 

 

CVG

 

The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

 

CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

A Day in the Life
Responsible for mentoring/leading other members of the team, as requested

Participate and Demonstrate Subject Matter Expertise in CAPA activities:

 

  • Timely management of CAPA activities

  • Investigation/root cause determination

  • Action Planning and Execution

  • Effectiveness Planning and Execution

  • Coaching and Mentoring other CAPA Owners

Investigate product and process quality Issues:

  • Investigation/root cause determination
  • Generate risk assessment evaluations

  • Investigate customer complaints 

Manage Nonconforming Product Dispositions

  • Participate in Material Review Board as required

Support all Third party and Internal Audits

  • Provide back room and SME support
  • Conduct internal audits

Performs other related duties as assigned

Responsibilities may also include the following and other duties may be assigned.Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors Degree in Engineering or Science field with 4+ years of work experience in Engineering and/or Quality OR Masters Degree in Engineering or Science field with 2+ years of work experience in Engineering and/or Quality.

 

Nice to Have

  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2003n and JPAL

  • CAPA experience

  • Experience working in a team environment

  • Six-Sigma greenbelt or blackbelt certification

  • Working knowledge of problem solving and statistical methods as applied to process and product quality.

  • Strong English verbal and written communication and presentation skills.

  • Proficiency in MS Office, including Word, Excel, Outlook, and PowerPoint.

  • Certified Lean or Six Sigma Black Belt.

  • Project Management experience.

  • ASQ certification in Quality, Reliability or Software QA.

  • An ability to influence cross-functional teams and people at various levels in the organization

  • Self-Starter and accountable, with sharp focus on quality and customer experience.

 

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
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