MedTech Process Engineering Manager: Yield & Validation

BD; Kulim; On-site; MYR 89,000 - 134,000; Full time

Job summary

BD in Malaysia (Kedah, Kulim) seeks to optimize Compounding and Catheter Offline Dipping Equipment (CODE) operations. You will manage CODE operations, qualification activities for new and alternate materials, and lead cost/quality improvements.

You will support business continuity, manage project schedules, prepare design specs, and oversee catheter validation programs. You may also advise process engineers on yields and quality and perform other supervisor-directed tasks.

Responsibilities

• Manages and supervises the Compounding and Catheter Offline Dipping Equipment (CODE) operations
• New replacement material qualifications to support Business continuity (Stay in Business)
• Alternate material qualifications to support cost/quality improvements
• Identify opportunities for Materials waste reduction
• Value Engineering for Cost and/or Quality related opportunities on current and future products
• Manage project schedules and timelines
• Prepare project documentation including capital requests, design specifications
• Management of catheter IQ/OQ/PQ validation programs
• Consultant to Process engineers on yield or quality improvement activities
• Other assignments as instructed by immediate Supervisor

Job description

BD in Malaysia (Kedah, Kulim) seeks to optimize Compounding and Catheter Offline Dipping Equipment (CODE) operations. You will manage CODE operations, qualification activities for new and alternate materials, and lead cost/quality improvements.

You will support business continuity, manage project schedules, prepare design specs, and oversee catheter validation programs. You may also advise process engineers on yields and quality and perform other supervisor-directed tasks.