Responsibilities
Develop and enhance process control systems to drive continuous improvement in product quality, focusing on reducing Cost of Poor Quality (COPQ) and customer escapes.
Manage customer feedback effectively to enhance satisfaction by collaborating with cross-functional teams, addressing customer requirements, and expediting quality issue resolution.
Initiate problem-solving activities and improvement programs, working closely with manufacturing and engineering teams to achieve both short- and long-term product improvements.
Manage process and product change control to ensure that all modifications are documented, evaluated, and approved according to established protocols.
Oversee quality deliverables in NPI projects, including the creation of control documentation, establishing process controls, and training quality inspectors.
Enforce compliance with quality systems such as ISO 9001 to ensure all products meet regulatory requirements.
Facilitate root cause analysis for product quality issues, implementing corrective actions as necessary to prevent recurrence.
Work closely with Engineering, Production, and Supply Chain teams to define quality parameters and ensure effective process capability.
Provide clear, complete, and accurate documentation of inspection results, test data, and quality metrics; prepare reports for management review.
Lead initiatives aimed at improving product quality, reducing defects, and enhancing overall manufacturing processes.
Basic Qualifications
Educational Background: Bachelor's degree in any field or Quality Management; a master's degree is preferred.
Experience: Minimum of 5 years of experience in product quality assurance within a manufacturing environment; experience in the medical device or electronics industry is highly advantageous.
Strong understanding of quality management systems (QMS) including ISO 9001.
Proficiency in using quality assurance tools such as Six Sigma methodologies (Green Belt certification preferred), FMEA (Failure Mode Effects Analysis), SPC (Statistical Process Control), and PPAP (Production Part Approval Process).
Familiarity with regulatory standards relevant to manufacturing processes.
Preferred Characteristics
Ability to work independently while also collaborating effectively within cross-functional teams.
Knowledge of materials and processes used in manufacturing such as plastics, sheet metal fabrication, PCBA (Printed Circuit Board Assembly), etc.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) for data analysis and reporting.
Ability to clearly articulate technical information to diverse audiences; strong written communication skills for documentation purposes.
Proven ability to work collaboratively within cross-functional teams while also demonstrating independence when required.
Meticulous approach to reviewing processes, documentation, and inspection results to ensure accuracy and compliance.
Capacity to adjust strategies based on changing circumstances within the manufacturing environment or project requirements.#J-18808-Ljbffr