Please follow application instructions found at end of posting.
We are seeking a Quality Engineer. The successful candidate will possess the following skills: strong technical background, attention to detail, ability to multi-task, ability to work effectively in cross-functional teams, experience in developing and implementing department initiatives, and excellent interpersonal communication. Must be eligible to work in the US without company sponsorship. Please see summary below.
The Quality Engineer is a technical position assuming various years of experience and different job roles. An Engineering degree or equivalent is required. The job performance requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems. The Quality Engineer will work closely with AtriCure engineering, manufacturing and suppliers to ensure that Quality System activities are completed. This individual will have a strong technical foundation and must be able to coordinate activities to meet the project / product release schedules. Additionally, he/she will have proven creativity and experience in planning, developing, and executing QA initiatives to regulatory compliance. Will be responsible for the development and implementation of company-wide quality systems. The systems require:
- Compliance with international and national regulations;
- Development to support quality system compliance activities;
- Ensure that the systems focus on continuous improvement.
Roles and Responsibilities
- Develop Quality systems and establish procedures in compliance to FDA regulations, MDD, CMDR and ISO requirements.
- Direct and support Suppliers, Engineering, Inspection, Calibration, Internal Auditing, CAPA, Quality Engineering and Document Control.
- Represents Quality for projects including new products and existing product improvement. Supports protocol, procedure, design controls and specification development.
- Work closely with Quality Management and other departments in developing and executing company strategies.
- Negotiation and problem solving skills.
- Assist with FDA and ISO audits. Perform internal and supplier audits as necessary.
- Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
- Familiarity with domestic and international standards and controls which are job related such as Risk Management, Sterilization, Inspection or other.
- Generally operates with appreciable latitude for actions and/or decisions on day-to-day activities. Receives or seeks guidance on novel or controversial problems that may impact the business significantly.
- Disposition of nonconformances.
- Development of corrective actions for Quality issues.
- Bachelor’s degree in engineering, or the equivalent.
- Five to ten years of experience.
- Ability to lead project activity and mentor less-experienced associates.
- Experience in inspection, testing, and data analysis.
- Excellent written and oral communication skills.
- Ability to read technical specifications, blueprints, and drawings.
- Some background in statistical analysis and in Quality auditing.
- Knowledge of ISO 13485.
- Supervisory experience.
- Strong organizational, attention to detail and time management skills to handle multiple projects and priorities.
- Able to exercise independent discretion and judgment to quickly analyze/ solve complex problems and propose efficient solutions.
- Strong computer skills including Windows XP, MS Word, Excel, PowerPoint, and the Internet, as well as the ability to learn and operate new programs as required.
- Ability to communicate and perform effectively with all levels of the organization and handle confidential information with professional demeanor and discretion.
- Ability to anticipate the expectations and needs of the organization in order to take a proactive approach in completing projects and problem recognition/ solving.
- FDA Audit experience
- Working in medical device industry
- Bachelor’s degree in engineering, or the equivalent
- Strong technical writing skills
- Supporting corrective and preventive actions (CAPAs), addressing nonconforming product, and conducting investigations
Desired but not required:
- MDD, CMDR, and JPAL knowledge
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor
- Familiar with software validation, including, FDA Part 11 compliance, development and execution of protocols (i.e., FRS, FDS, IQ,OQ, PQ)
- New product development (i.e. design controls)
- Performing internal and supplier audits
Compensation and Benefits
We offer a competitive compensation package to full-time hires. Our benefit package is comprehensive and includes medical insurance, life insurance, disability insurance, dental and vision insurance, flexible medical and childcare spending accounts, 401k, paid holidays and paid vacation, casual dress, creative workplace. Drug screen and background check required.
Preferred: go to http://www.atricure.com/Join_the_Team/Apply/. Please have your resume and a cover letter available for upload as a Word document. May also fax resume and a cover letter to 513-644-4751. Must have QUAL ENGR on the cover sheet. NO PHONE CALLS PLEASE.
Indeed - 6 months ago