Quality Assurance Technician II
Confluent Medical Technologies
Summary
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.
Job description
We are looking for a Quality Assurance Technician II to join our talented team in Chattanooga, Tennessee!
Essential Duties and 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.
Education and/or Experience
- High-school diploma, with college degree preferred.
- Two – three years of experience in medical industry preferred.
Other Skills and Abilities
- Proficient computer skills including electronic mail, record keeping, routine database activity, word-processing and, especially proficient in Excel (from intermediate to advanced knowledge). Experience in the medical device industry is an asset.
- Maintains a high degree of accuracy with strong attention to detail.
- 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.
- Customer service, quality focus, problem solving, documentation skills, confidentiality, analyzing information, and multi-tasking.
- 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.
- Basic computer skills (Microsoft Office, Windows, Internet)
Requirements
- High-school diploma
- Two – three years of experience in medical industry preferred
- Proficient computer skills including electronic mail, record keeping, routine database activity, word-processing
- Especially proficient in Excel (from intermediate to advanced knowledge)
- Maintains a high degree of accuracy with strong attention to detail
- 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
- Customer service, quality focus, problem solving, documentation skills, confidentiality, analyzing information, and multi-tasking
- Basic computer skills (Microsoft Office, Windows, Internet)
Benefits
- Competitive pay
Company overview
Confluent Medical Technologies is a leading medical device contract development and manufacturing organization (CDMO) that applies advanced materials science to MedTech innovation. Founded in 1991 and headquartered in Scottsdale, Arizona, the company specializes in the expert design, development, and large-scale manufacturing of interventional catheter-based devices and implants. With over 2,000 employees across eight state-of-the-art facilities in the United States and Costa Rica, Confluent has established itself as a trusted partner to major medical device companies worldwide. The company's core capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable biomedical textiles. Confluent's vertically integrated supply chain approach brings design, development, and manufacturing together under one roof, enabling faster time-to-market and greater innovation for its customers. The company serves the cardiovascular, neurovascular, and structural heart markets, providing life-saving solutions through its expertise in shape memory alloys and polymer technologies. Confluent Medical Technologies has earned the confidence of industry leaders through its proven track record of innovation, engineering excellence, and manufacturing reliability. The company's commitment to quality, safety, and customer satisfaction has positioned it as a critical partner in advancing minimally invasive medical technologies that improve patient outcomes globally.