Quality Assurance Technician II

Confluent Medical Technologies, Inc.; Chattanooga (TN); On-site; USD 48,000 - 65,000; Full time

Job summary

Confluent Medical Technologies, Inc. is seeking a Quality Assurance Technician II in Chattanooga, TN. The role focuses on reviewing quality docs for release, supporting calibration and QMS processes, and applying statistics to improve manufacturing outcomes.

You will participate in audits, assist in root cause investigations, and may supervise inspection staff. Strong Excel skills, Minitab knowledge, and familiarity with ISO 9001/13485 are highly valued.

Qualifications

• High-school diploma; college degree preferred.
• Experience in medical device industry a plus.
• Proficient in Excel and MS Office with strong data handling skills.
• Familiarity with ISO 9001/13485, FDA 820 or related quality tools is beneficial.
• Statistical knowledge (Six Sigma, QMS) is an asset.

Responsibilities

• Reviews manufacturing and quality documentation for product release to Shipping.
• Supports calibration management activities and QMS compliance.
• Plans and conducts evaluations and adapts standard techniques.
• Performs root cause investigations and supports audits.
• May supervise inspectors or operators on specific assignments.
• Participates in KPI achievement and safety adherence.
• Contributes to DCOs, ECOs, and validation activities.
• Maintains accurate records and documentation.

Skills

Excel proficiency

Microsoft Office suite

Minitab knowledge

Statistics understanding

Problem solving

Documentation skills

Attention to detail

Confidentiality

Multi-tasking

Customer service focus

Education

High-school diploma

College degree preferred

ISO 9001/13485 & FDA training

Tools

Minitab

Statistical methods

Job description

Job Description: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 RESPONSABILITIES 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.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)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.