Sr. Product Quality Assurance Engineer

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.