Job Description

Summary The QM Engineer I is responsible for gaining experience in the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems.

Learning to apply the Quality Systems to ensure compliance as well as having the knowledge necessary to apply the appropriate statistical and analytical tools. Works with various enterprise systems/Corporate directives to support new and/or current product lines and processes.

Typical assignments may include: developing/implementing tasks associated with plant activities or projects of general complexity within planned schedules/timelines, supporting audits, participating on teams, ensures documentation compliance, processing CAPAs, change control, and deviation waivers. Routine interaction with other functional areas such as Operations and other Quality groups.



The QM Associate Engineer is primarily responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. The QM Engineer I oversees QC operations within the instrument plant and assuring documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The QM Engineer I conducts complaint investigation, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.

Cost Center Specific:

1. Manage complaint handling, QN\'s, CAPA\'s, D/W\'s and trending for assigned instrumented platforms. Assist manufacturing in maintaining compliance with cGMP associated with the quality system procedural requirements for assigned platforms.
2. Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes
3. Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.
4. Work collaboratively with suppliers to part quality.

Primary Work Location MYS Penang - Bayan Lepas

Additional Locations

Work Shift

BD