(ONLY CANDIDATES WITH PREVIOUS GUIDEWIRE PROCESS EXPERIENCE WILL BE CONSIDERED)

Responsible for guidewire transfer products, establishing and improving quality assurance practices and procedures, evaluating quality sampling plans and inspection methods. Reviews/recommends solutions to quality problems. In addition, this position is responsible for developing, implementing, maintaining and improving appropriate quality system elements to ensure a high level of quality for existing products as well as new products transferred to the site.

Responsibilities

· Transfer products from other sites. Meet established delivery times.

· Write, review, and/or approve validation protocols and reports (e.g., cleanroom, test method, and product transfer validation protocols).

· Provide quality-engineering support for sustaining activities related to guidewires, resolving quality issues, and working on improvement projects.

· Participate in determining product containment, investigating nonconforming material, recommending disposition (Material Review Board), and facilitating root cause determination, corrective/preventive action (internal & supplier), including CAPA ownership as appropriate.

· Create, revise, and approve departmental procedures and documentation required for quality activities.

· Evaluate and recommend inspection gauges and test equipment.

· Collaborate with manufacturing to recommend in-process and final inspection strategies to ensure product quality at each stage of manufacturing and study the effectiveness of inspection activities.

· Leads or assists in process improvement projects and provides technical input and assistance in activities such as Quality Planning, Risk analysis, and FMEA.

· Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques, and other QA engineering areas.

Education & Experience

· Bachelor's degree in Industrial Engineering or related area.

· 3 – 5 years of progressive experience in the medical device industry

· At least 3 years supporting guidewires manufacturing process

Other

· Knowledge of statistical analysis tools and familiarity with equipment and process validation.

· Familiarity with Minitab or any equivalent statistical tool is required.

· English B2 – C1

· Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements

· ASQ CQE/CSSBB will be considered a plus

· Project Management experience is a plus

· Proactive problem-solving, including root cause analysis and DOE