Job Description:
•Responsible for managing quality systems, processes, and procedures to assure product quality and safety.
•Overview, follow up and guidance of routine QA/QC activities such as CAPA, NCMRs, ECO, SCAR (customer compliant), incoming inspection, in process inspection, final inspection, product release.
•Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.
•Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive quality system requirements.
•Build quality monitors for the company management
•Communication with regulatory and certification agencies
•Responsible for Internal audits and suppliers’ audits, certify suppliers to required standards. Lead external audit preparation
•Manage team of quality engineers and quality control personnel.
Direct Manager: Company’s VP of QA
Education: A degree in science / medicine / Engineering
Job Skills:
o At least 5 years of work experience in a similar position
o QA management experience in a medical device company
o Solid experience in ISO and FDA Audits
o Experience in working with medical device standards – an advantage
o Experience in working with manufacturing companies – an advantage
• Computer Skills: Microsoft (Excel, word, ppt, visio)
• Language skills: Fluent English (written and verbal)
Personality:
o Excellent problem solving and decision-making skills, ‘out of the box’ thinker
o Interpersonal skills that foster conflict resolution.
o Excellent verbal and presentation skills.
o Mentoring and teaching abilities.
o Excellent interpersonal relationship, team player.
o Self-motivated, Independent.
o Able to work under pressure
