Quality Engineer II - Warwick, United Kingdom - Confluent Medical Technologies

Description

Job Description

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, 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're looking for a Quality Assurance Engineer II to join our Warwick team. As a uniquely qualified candidate, you will:

• Coordinate and maintain equipment calibration schedule and status using designated online database; as well as maintaining and updating equipment files where necessary.

• Maintain CAPA files and coordinate CAPA investigation, root cause analysis, corrections, corrective actions to prevent reoccurrence, and effectiveness of the CAPA System.

• Be responsible for Confluent customer communication website to process customer communications/requests/complaints and make assignments to Complaint Handling system, product returns (RMAs), or route requests to customer solutions. Review Customer Complaints files and coordinate complaint investigation assignment and follow up on progress.

• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, hypothesis testing, regression analysis, calculation of confidence / tolerance intervals, and Design of Experiments (DOE)

• Perform customer specification change request reviews for internal capabilities, process exceptions back to customer for finalization of specification approval. Perform new product contract and specification review approvals in ERP and Quality Management SW systems.

• Develop quality assurance specifications, test methods, sampling plans and related written procedures. Be able to perform and assist test method validations.

• Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.

• Support Quality Control inspection for continuous improvement, resolve inspection issues, customer documentation and certification corrections from customer complaints. Qualify and implement document changes involving product or process changes.

• Support manufacturing and process Non-conformance (NCR) processing for medical products & coordinate root cause analysis, reporting of Non-Conforming Products, Customer Complaints and Return Products.

• Provide quality engineering support to quality control and provide guidelines on inspection methods and equipment used including measuring systems capabilities.

• Generate metrics and monitor product nonconformance trends in order to alert senior management of these trends so corrective action plans can be evaluated.

• Complete projects in a manner of consistent with corporate objectives.

• Work with the Manufacturing, Sales and Marketing, Research and Development functions to coordinate production of new process validations and risk analysis (FMEA) for site development projects.

• Support product/line extension projects involving risk analysis, Master validation plan, product V & V, Process Validations and transfer design to manufacturing.

• Develop, implement and provide technical support of Quality Plans.

• Perform other Quality related tasks as needed.

• Follow all safety and production standard operating procedures.

• Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for EH&S compliance.

Additional Qualities:

• Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Reasoning Ability: Have the ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

• Communication: Both written and oral communication are an essential part of the role. Prompt communication and transparency are the key to success within the department, organization and Confluent-customer relationship.

• Must be self-motivated & multi-task oriented. Must also have excellent technical, written and verbal skills and be highly organized.

Education and Experience:

• Must have a degree in science or engineering and at least 3-6 years of experience in Quality Assurance and/or Quality Engineering.

• Knowledge of product development, process optimization, and failure analysis, FMEA, Risk Analysis, and Verification/Validation activities.

• Knowledge in international standards (ISO and FDA Regulatory codes is preferable

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.