Quality Engineer II
Quality Engineer, II
Full Time Technical
Austin, TX, US
This company is dedicated to working collaboratively with our customers, taking 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 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.
This company is growing! We’re looking for a Quality Engineer II to join our Austin, TX team.
As a uniquely qualified candidate, you will:
- Maintain CAPA files and coordinate CAPA investigation, root cause analysis, corrections, corrective actions to prevent reoccurrence, and effectiveness of the CAPA System.
- Responsible for the company’s customer communication website to process customer communications/requests/complaints and make assignments to Complaint Handling system, Equipment Returns (RMAs), or route requests to customer solutions.
- 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.
- Review Customer Complaints files and coordinate complaint investigation assignment and follow up on progress.
- Develop quality assurance specifications, test methods, sampling plans and related written procedures.
- 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 pilot balloon and extrusion 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.
- Performing other Quality related tasks as needed.
To perform the job successfully, an individual should demonstrate the following competencies:
- Problem Solving - Gathers and analyzes information skillfully.
- Interpersonal - Maintains confidentiality.
- Oral Communication - Listens and gets clarification.
- Written Communication - Varies writing style to meet needs.
- Attendance/Punctuality - Is consistently at work and on time.
- Dependability - Follows instructions, responds to management direction.
- Planning/Organizing - Organizes or schedules other people and their tasks.
- Professionalism - Treats others with respect and consideration regardless of their status or position.
- Quality - Monitors own work to ensure quality.
- Quantity - Works quickly.
Education and Experience
- Must have a degree in science or engineering and at least 4 years of experience in Quality Assurance and Quality Engineering.
- Must be self-motivated & multi-task oriented. Must also have excellent technical, written and verbal skills and be highly organized.
- Knowledge of product development, process optimization, and failure analysis, FMEA, Risk Analysis, and Verification/Validation activities.
- knowledge in international standards and FDA Regulatory codes
Certificates, Licenses, Registrations
Preferred an ASQ (CQE).
This company offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.
We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.
This company is an equal opportunity employer.