The Quality Manager is a manufacturing quality specialist responsible for developing and managing the Quality Management System; oversees Quality inspection of processes and products; assures and certifies product compliance. Maintains quality system conformance, quality data collection/reporting, Field Return system/analysis, and Corrective and Preventive Action system. A key part of the role is to ensure 100% quality product is manufactured on a first time basis through process control and effective production techniques. This requires a highly integrated and hands on approach with engineering and production operations.
Establishes quality standards and metrics for new processes with Engineering and Operations, defining methods & standards to improve product quality and productivity. Active in Genba Kaizan activities company wide.
Coordinates/manages the scheduling and control of inspection activities and enforcement requirements for raw materials, components, product and package specifications and regulatory agencies.
Determines overall plant product quality by coordinating the implementation of methods and procedures for inspecting, testing and evaluation of products and production equipment.
Maintains compliance with all documented Quality Policies and Objectives; assists in obtaining and maintaining required Quality certifications.
Assists in resolving quality problems by driving efforts of quality, engineering, and operations personnel to identify root causes of problems and appropriate corrective and preventive action.
Coordinates field return/ failure analysis system, calibration, change control and material review board.
Act as front line for customer concerns on quality issues or related technical questions.
Establishes and maintains effective inspection and tests to ensure product quality/reliability.
Ensure compliance with all corporate directives or initiatives for quality, control processes etc. Achieve compliance. Act as instructor, facilitator, coordinator and auditor to ensure implementation is effective.
Coordinates quality data collection and reporting system.
3+ Years of experience with FDA Medical Device Manufacturing (ISO 13485)
Bachelors degree in Engineering or Science based discipline
6+ Years of experience working in Quality
Eligible to work in the United States without sponsorship
Solid knowledge of Design Controls, Quality Control and assurance practices.
Internal Audit experience
Change Control and Supplier Management experience
Knowledge and Practical implementation of ISO 9001 and ISO 13485
Prior practical experience with 6 Sigma, SPC, Cpk, AQPQ, PPAP
RoHS/REACH/SVHC/IMDS reporting is desired
JE offers talented employees exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.