Quality Assurance Technician II

Confluent Medical Technologies•Chattanooga, TN

About The Position

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. We offer competitive pay and benefits to recognize the important role you will play in our life-saving work. We are looking for a Quality Assurance Technician II to join our talented team in Chattanooga, Tennessee! ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned: Reviews manufacturing and quality documentation to authorize product release to Shipping and final release to the customer. May support calibration management activities and review documentation for compliance with Quality Management System (QMS) requirements. Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Devises new approaches to problems encountered. Independently performs most assignments with instructions as to the general results expected. Supports quality engineering with work which involves conventional engineering practice but may include a variety of complex features such as reducing sampling plans and using statistics to reduce the issues. Support quality engineering in DCOs, ECOs and running validation protocols and reports. May technically supervise or coordinate the work of inspectors and operators or others who assist in specific assignments. Be aware and work to achieve the Key Performance Indicators (KPIs). Practices company safety, quality policies and procedures, actively requires conformance. May require conducting internal audits. Support in root cause investigations. Support internal and external audits. Other duties in the Quality Assurance areas. Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers. We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position. Confluent Medical Technologies is an equal opportunity employer. Only qualified candidates will be contacted. Applying materials science to MedTech innovation. Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheter-based devices and implants. Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees. Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing. Visit www.confluentmedical.com to learn more.

Requirements

High-school diploma, with college degree preferred.
Two – three years of experience in medical industry preferred.
Proficient computer skills including electronic mail, record keeping, routine database activity, word-processing and, especially proficient in Excel (from intermediate to advanced knowledge).
Maintains a high degree of accuracy with strong attention to detail.
Customer service, quality focus, problem solving, documentation skills, confidentiality, analyzing information, and multi-tasking.
Basic computer skills (Microsoft Office, Windows, Internet)

Nice To Haves

Experience in the medical device industry is an asset.
Training in ISO 9001/13485 requirements, FDA part 820 or other quality tools (Problem Solving,Technical Writing, FMEA, Process Validation) is an asset.
Training in Statistics, Six Sigma or Quality Engineering, Quality Management or Sterilization is an asset.
Knowledge of statistics and Minitab is an asset.

Responsibilities

Reviews manufacturing and quality documentation to authorize product release to Shipping and final release to the customer.
May support calibration management activities and review documentation for compliance with Quality Management System (QMS) requirements.
Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
Devises new approaches to problems encountered.
Independently performs most assignments with instructions as to the general results expected.
Supports quality engineering with work which involves conventional engineering practice but may include a variety of complex features such as reducing sampling plans and using statistics to reduce the issues.
Support quality engineering in DCOs, ECOs and running validation protocols and reports.
May technically supervise or coordinate the work of inspectors and operators or others who assist in specific assignments.
Be aware and work to achieve the Key Performance Indicators (KPIs).
Practices company safety, quality policies and procedures, actively requires conformance.
May require conducting internal audits.
Support in root cause investigations.
Support internal and external audits.
Other duties in the Quality Assurance areas.
Practices company safety, quality policies and procedures, actively requires conformance.
Comply with all safety policies, practices and procedures.
Report all unsafe activities to supervisor and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Perform other duties as assigned.