Senior Product Quality Assurance Engineer

PerkinElmer; Johor Bahru; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading company in analytical services is seeking a Senior Product Quality Assurance Engineer in Johor Bahru. The role involves enhancing product quality through process control, managing customer feedback, and ensuring compliance with quality systems. Ideal candidates will have a strong engineering background and experience in quality assurance within manufacturing, particularly in medical devices or electronics. Join a dedicated team to drive continuous improvement and achieve excellence in product quality.

Qualifications

• Minimum of 5 years of experience in product quality assurance.
• Strong understanding of ISO 13485 and ISO 9001.

Responsibilities

• Develop and enhance process control systems for product quality.
• Manage customer feedback and collaborate with cross-functional teams.
• Lead initiatives to improve product quality and reduce defects.

Skills

Quality Management Systems

Problem Solving

Collaboration

Documentation

Data Analysis

Education

Bachelor’s degree in Engineering

Master’s degree

Tools

Six Sigma

FMEA

SPC

PPAP

Microsoft Office Suite

Job description

Senior Product Quality Assurance Engineer

PerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and management and today complements its service offerings with a broad portfolio of atomic spectroscopy, molecular spectroscopy, and chromatography instruments, consumables, and reagents. With a dedicated team of more than 5,000 team members, the Company serves customers in more than 35 countries. Additional information is available at www.perkinelmer.com

Responsibilities

1. Develop and enhance process control systems to drive continuous improvement in product quality, focusing on reducing Cost of Poor Quality (COPQ) and customer escapes.
2. Manage customer feedback effectively to enhance satisfaction by collaborating with cross-functional teams, addressing customer requirements, and expediting quality issue resolution.
3. Initiate problem-solving activities and improvement programs, working closely with manufacturing and engineering teams to achieve both short- and long-term product improvements.
4. Manage process and product change control to ensure that all modifications are documented, evaluated, and approved according to established protocols.
5. Oversee quality deliverables in NPI projects, including the creation of control documentation, establishing process controls, and training quality inspectors.
6. Enforce compliance with quality systems such as ISO 9001, ISO 13485, and QSR820 to ensure all products meet regulatory requirements.
7. Facilitate root cause analysis for product quality issues, implementing corrective actions as necessary to prevent recurrence.
8. Work closely with Engineering, Production, and Supply Chain teams to define quality parameters and ensure effective process capability.
9. Provide clear, complete, and accurate documentation of inspection results, test data, and quality metrics; prepare reports for management review.
10. Lead initiatives aimed at improving product quality, reducing defects, and enhancing overall manufacturing processes.

Basic Qualifications

• Educational Background: Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial) 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 13485 and 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.