ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
· Maintain and comply with the requirements of ISO13485, 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.
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 ISO13485, 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.
