Department: Quality

Reports To : Senior Quality Engineer / Quality Manager

Job Summary

The Quality Engineer is responsible for the product quality activities within Creganna Medical Singapore
Operations. This will include support for new product development and transfers.

Essential Duties And Responsibilities

Include the following. Other duties may be assigned.

 Maintain and comply with the requirements of IS013485, GMP, FDA 21 CFR Part 820 and other
applicable regulations.
 Participate in the internal and notified body audit programs as required.
 Management of MRR activities.
 Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality
inspections,
 Ensure that non-conforming products are properly handled via Non-Conforming Materials Review
(NCMR) process.
 Establishing inspection standards, plans, frequencies and test methods.
 Lead and drive QA initiatives across the product areas.
 Support and drive cost improvement project
 Investigating root cause of quality issues and following through with timely and effective
corrective actions to prevent re-occurrence.
 Drives robust and effective corrective and preventive action programs through the CAPA system.
 Strategically lead new product introduction from a QA perspective.
 Overall responsibility for production GMP standards and compliance, also including cleanroom
requirements.
 Participate in new product introductions to ensure quality is built into all products early in their life
cycle
 Support Production on all quality-related activities, including working closely with Engineering and
other applicable functions.
 Assist in the investigation and analysis of customer complaints and follow-up with the relevant
functions to ensure that they are addressed & closed in a timely manner.
 Assist in the definition of qualification/validation processes and the development of protocols in
conjunction with appropriate functions.
 Supervision and direction of other Quality personnel.
 To support audits from customers and external regulatory agencies (FDA, BSI etc)
 Participates in Customer Complaints investigation for areas under their control and escalates
critical issues as appropriate.

Other Quality Personnel Where Required.

SUPERVISORY RESPONSIBILITIES:
Education/ Experience And Qualifications

 Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably

in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years'
relevant experience may be considered
 Excellent communication & project management skills.
 Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.
 Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
 Knowledge of IS013485, FDA 21 CFR Part 820, and/or the Medical Device Directives.
 Proven abilities in decision making and sound personal judgement. Good organization,
supervisory and investigation skills are required.
 Proven ability to influence.
 Experience in Sterilization (ETO) is preferred.

Work Environment

While performing the duties of this Job, the employee is frequently exposed to moving mechanical
parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.