QA Technician

Job Description:

onfluent 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, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. 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 are looking for a QA Technician I to join our team. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.

SUMMARY: Works on problems and projects of limited scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, supports selection of equipment, provides and develops solutions to problems of limited scope. Must be able to accomplish simple and general assignments. May provide technical guidance to quality inspectors and operators.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Supports the development, application, maintenance to quality standards for processing materials/products into partially or finished products.
• Contributes in the designs and implementation of methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of measurement systems and test methods, products and/or production equipment.
• Analyzes reports and returned products and recommends corrective action.
• Prepares documentation for inspection/testing procedures.
• 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.
• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work a in tasks of moderate scope.
• Support 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 coming across.
• 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, war room others.
• Other duties in the Quality Assurances area.
  
  

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No

Leadership: N/A

Supervises: N/A

Supervision:

General Direction: receive guidance with respect to specific objectives; work is usually quite independent of others; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE: Technical degree (i.e from a Technical High School or INA). Also 2-3 years of experience in medical industry.

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 advance knowledge). Experience in the medical device industry would be an asset. Training in ISO 9001/13485 requirements, FDA part 820 or other quality tools (Problem Solving, Technical Writing, FMEA, Process Validation) would be an asset. Training in Statistics, Six Sigma or Quality Engineering, Quality Management or Sterilization would be an asset.

English (at least 50%: reading, writing, speaking and listening).

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)

MANUAL DEXTERITY: No special requirements

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Saturday.

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

Able to work inside a Cleanroom at least 90% of the time.

PHYSICAL DEMANDS

Other physical working conditions:

Lifting or carrying items.

Moderate noise

PHYSICAL ACTIVITY LEVEL: Moderate physical activity performing somewhat strenuous daily activities of a primarily administrative nature.

COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.