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.At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.We are looking for a Quality Assurance Engineer, Staff to join our team in. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you! Summary: Provides direct support to the manufacturing lines. Ensures that the products are being built according to the manufacturing procedures. Ensures that products built meet all the Customer specification requirements.The Quality Assurance Engineer Staff should be capable of preparing, analyzing and reviewing/approving. Engineering and Quality Records related to manufacturing process changes, documentation updates, root cause investigations, validation protocols, etc without guidance from Supervisor/Coach. Monitors department metrics and presents information when required to other members of the organization. Serves as direct Coach/teacher for Quality Assurance Engineers 1 and 2. It is expected to solve issues by its own and provide recommendations/solutions to different unexpected situations/problems.EDUCATION and/or EXPERIENCE:Bachelor's degree in a related engineering discipline; 4-6 years of related experience.Proficient oral and written English level.Knowledge of statistics and Minitab is a must.Experience in the medical device industry. Certification and/or license in specific discipline . Certified Quality Engineer. Training as Internal Auditor in ISO 9001, 13485 or Biomedical field would be an asset.OTHER SKILLS and ABILITIES:Work requires a good knowledge of precedents, principles and practices in the specialty area. Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset.Customer service, quality focus, problem solving, market knowledge, documentation skills, confidentiality, analyzing information, multi-tasking, and project management skills.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.Provide leadership to others through example and sharing of knowledge/skill.Ability to read, analyze, and interpret technical documents. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to public groups among the natural working team, customers, regulatory members or business community.Ability to define problems, collects data, establishes 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.Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.Ability to teach/coach QEs 1 and 2 in order to support them in their professional development.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.
