Senior Manager Quality Engineering

The Senior Manager, Quality Control is responsible for leading all quality control

activities relating to CNC-machined medical devices. The role ensures that all

machined products meet engineering drawings, customer specifications, and

regulatory requirements prior to release.

This position provides hands-on leadership over inspection systems, measurement

methods, and nonconformance management, while supporting manufacturing

excellence and customer satisfaction in a contract manufacturing environment.

Key Responsibilities

1. CNC Machining Quality Control

• Lead all QC activities for CNC-machined products, including in-process and final inspection.

• Ensure conformance to:

• Engineering drawings and GD&T requirements
• Customer specifications
• Applicable regulatory and quality standards

• Approve inspection plans, control plans, and acceptance criteria for machined

products.

• Provide technical guidance on machining-related quality issues such as

tolerances, surface finish, burrs, and dimensional variation

2. Inspection & Measurement Systems

• Oversee the use and capability of inspection equipment including:

• CMM (Coordinate Measuring Machines)
• Optical measurement systems
• Surface roughness testers
• Gauges, micrometers, calipers, and fixtures

• Ensure measurement system analysis (MSA) is performed and maintained.

• Ensure calibration and maintenance of all inspection and measuring equipment.

• Drive improvement of inspection efficiency and accuracy.

3. Nonconformance & CAPA Management

• Lead the management of nonconforming CNC-machined products, including

segregation, disposition, and documentation.

• Drive root cause analysis for machining-related defects and dimensional

nonconformities.

• Ensure effective corrective and preventive actions (CAPA) are implemented and

verified.

• Monitor defect trends and machining capability to prevent recurrence.

4. Manufacturing Support & Process Control

• Partner with Manufacturing and Engineering teams to:

• Support CNC process capability and stability
• Review machining process changes and deviations
• Support NPI and machining transfers, including attending to customer
• transfer calls/online meetings

• Participate in process validation (IQ/OQ/PQ) related to CNC machining and

inspection processes.

• Ensure quality requirements are embedded in shop-floor practices.

5. Supplier & External Processing Quality

• Oversee QC activities related to outsourced machining, finishing, or secondary

processes (if applicable).

• Support supplier quality inspections, evaluations, and issue resolution.

• Ensure incoming machined components meet specifications prior to use.

6. Customer Quality Interface

• Act as the primary Quality Control contact for CNC machining-related customer

issues.

• Support customer audits focused on machining, inspection, and product

conformity.

• Provide technical responses to customer quality concerns related to

dimensions, tolerances, and surface conditions.

• Support first article inspections (FAI) and PPAP-like requirements where

applicable.

7. Quality Systems

• Ensure QC activities comply with ISO 13485, FDA 21 CFR Part 82 and other

related regulatory requirements.

• Ensure inspection records, batch records, and DHRs are complete and accurate.

• Support internal and external audits related to machining and inspection

processes.

• Ensure personnel competency and training for inspection activities.

8. Leadership & Team Development

• Lead, mentor, and develop the Quality Control team, including inspectors and QC Engineers.

• Establish clear QC KPIs and performance expectations.

• Promote discipline, accuracy, and accountability in inspection activities.

• Drive a strong shop-floor quality culture.

Qualifications

• Candidate must possess at least a Degree in Mechanical Engineering, Manufacturing Engineering or Industrial Engineering.

• Required skill(s): MS Office, MS Excel, knowledge in ISO 9001, ISO 13485, FDA or

21 CFR Part 820 is an added advantage.

• Required language(s): Bahasa Malaysia, Chinese, English.

• At least 10 year(s) of working experience in quality within the medical device or precision engineering industry.

• Experience in a contract manufacturing (CMO) environment is highly preferred.

• Prior experience supporting global OEM customers is an advantage.