Senior Supplier Quality Engineer
Summary
Senior Supplier Quality Engineer ensures medical device suppliers meet FDA, ISO, and international regulations through audits, quality plans, and corrective actions for AtriCure’s cardiac ablation technologies.
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.
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.
POSITION SUMMARY:
This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics
- 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.
- Supplier change requests and improvement
- Work closely with Quality Management, Product Development, and other departments in developing and executing company strategies
- Able to support both New Product Development activities at suppliers as well as sustaining activities for existing components and subassemblies.
- Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet regulatory requirements
- Assist with FDA and ISO audits. Perform internal and supplier audits as necessary
- Strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position
- Operates with appreciable latitude for, and assumes ownership of, actions and/or decisions on day-to-day activities.
- Determines appropriate response to novel or controversial problems that may impact the business significantly
- 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 required or demonstrated equivalent combination of education, training and experience.
- 4+ years of experience
- FDA and ISO 13485 knowledge and audit experience
- Willingness to travel
- Experience with inspection/testing and data analysis
- Strong computer/data entry, report writing, and communication skills
- Details-oriented with strong problem solving/trouble shooting experience
- Must be able to read technical specifications, blueprints, and drawings
- Engineering/design background
- Ability to travel 25%
PREFERRED QUALIFICATIONS:
- MDD, CMDR and JPAL knowledge
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor or ISO13485 Lead Auditor certification
- Statistical use experience
- Experience with Metal Injection Molding (MIM) suppliers
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
- Ability to pass pre-employment drug screen and background check
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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: .
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
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