Quality Manager

Description

• · Manages plant quality staff across quality systems and product quality.
• · Oversees the quality and documentation system and quality records program.
• · Responsible for execution of Design Verification and Process Validation for site projects.
• · Manages QMS processes for management review, CAPA, and internal audit.
• · Manages and provides resources for quality engineering, supplier quality, inspection, measurement, and test, complaint handling, non-conforming product and MRB resolution.
• · Ensures procedural compliance to FDA QSR, ISO, MDD and other applicable requirements.
• · Acts as site Management Representative for the TEM quality system.

• · Five or more years of quality management and leadership experience in managing multiple departments in quality and/or engineering support functions.
• · A background in medical device manufacturing.
• · Regulatory affairs experience.
• · Technical discipline or quality professional training.
• · Statistical techniques, metrology, and process analysis training.
• · Quality system design and implementation experience.
• · Risk management training.
• · Regulatory requirements and reporting responsibilities.
• · Supply chain development and management.
• · Strong analytical skills and attention to detail.
• · Excellent interpersonal and written communication skills.
• · Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decisions and solve problems independently.
• · A thorough knowledge of 21 CFR 820 and ISO 13485.