We are a Recruiting Firm and one of our best Medical Device Manufacturing clients, with offices in Phoenix/Tempe AZ area, is looking for an experienced Sr. Quality Engineer to ensure that products and processes meet all requirements established by global guidelines and regulatory authorities.
From Them:
WHY WORK FOR US:
· Bleeding-Edge, Global Company, leader in its industry, making the world a better place
· Company experiencing sustained health and growth
· Excellent Compensation and Stellar Benefits.
· Super Healthy Work Environment – Love where you work
WHAT YOU’LL BE DOING:
· Support and review Design Control activities for new products or process development, including design and development planning, design reviews, design input/output, design verification/validation, design history files, design transfer, risk management, etc. Coordinate the development of product DHF.
· Develop, implement/ maintain procedures for Design Control that adheres to ISO 13485 standards and FDA Quality System Regulation, ISO 14971.
· Provide quality engineering support in design and development of medical device products to ensure that quality requirements are translated into product and process functional specifications. Provides technical leadership to support product transfers and launches in compliance with Design Control and other applicable procedures.
· Utilize risk-based approach to assess and control design and manufacturing changes.
· Develop and/or review of product/process development documentation, method validation documentation, software/computer system validation documentation, and process validation documentation.
· Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the design development process.
· Lead statistical analysis for sampling plan rationale and analysis, including but not limited to, DOEs, Paretos, ANOVA, and SPC applications.
· Analyze data from the Design and Manufacturing of the products and identify opportunities for improvement.
· Provide support to maintain Quality System Regulation requirements including internal and external audits of Quality System.
· Works closely with Regulatory Affairs, Research and Development, Manufacturing, Clinical and other functional groups, to ensure compliance to applicable standards (external and internal) such as ISO 13485, ISO 14971, and FDA QSR/GMP.
· Sets Quality objectives and ensures that targets are achieved.
· Participates, personally or through representatives, in Regulatory Agency Inspections of the facilities and ensures corrective actions are done as necessary.
· May supervise RAQA personnel.
EXPERIENCE & SKILLS YOU’LL NEED FOR THIS POSITION:
· Average of 10 years related experience in the medical device field, including experience at management level.
· Effectively communicate within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
· Technically sound in quality systems and be abreast of developments in the Quality Assurance field. Including practical application of ISO 13485 and FDA Quality System Regulation 21 CFR part 820.
· GCP or GMP experience is a plus.
· Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred.
· Effective coaching, management, and mentoring skills.
· Knowledge of MS-Office.
· BS Engineering or Science Discipline.
We look forward to speaking with you.