Senior Supplier Quality Engineer

2 weeks ago

Dayton, United States AtriCure Full time

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

**This position is onsite at our Mason, OH location. Candidates must be able to commute to Mason or have the ability to relocate in order to be considered.

POSITION SUMMARY:

This position will be responsible for the development and implementation of supplier-related quality system requirements to comply with international and domestic regulations in support of new product development, manufacturing, change management, and quality management system activities with a focus on continuous improvement.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Direct and support supplier-related activities, including:
    • QMS qualification and monitoring including supplier audits and assessments
    • Component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc.
    • Correction activities including managing NCRs and SCARs.
    • Suppliers change requests and improvement.
    • Knowledge of supplier's QMS operational linkages to ATRC requirements.
  • Use strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position.
  • Work cross-functionally to overcome challenges and facilitate cooperation with suppliers to meet regulatory requirements.
  • Operate with appreciable latitude for, and assume ownership of, actions and/or decisions on day-to-day activities.
  • Determine appropriate response to novel or controversial problems that may impact the business significantly.
  • Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics.
  • Work closely with Quality Management and other departments in developing and executing company strategies.
  • Assist with FDA and ISO audits. Perform internal and supplier audits as necessary
  • Uses knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE's. Other duties as necessary and assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable work performance
  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned

BASIC QUALIFICATIONS:

  • Bachelor's degree (Engineering preferred) required or demonstrated equivalent combination of education, training and experience.
  • 4+ years collective experience in a manufacturing discipline used to manufacture components (ie. Machining, Molding, MIM, Forming, etc)
  • 2+ years ISO and regulated industry knowledge and audit experience.
  • Knowledge of inspection methods for tangible components (ie. Mics, Calipers, Vision System, CMMs, etc)
  • and
  • Ability to travel to local supplier(s) location(s) when required.
  • Ability to travel to out-of-town suppliers (approx

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