we are looking for a Quality Compliance Manager
Essential Duties and Responsibilities:
Exhibit a strong quality first mentality and ensure that QMS processes are held to the highest standard, Support the sites continuous quality improvement projects.
Lead QA Specialists/Engineers in the day-to-day activities- supervise and monitor over the employees performance and tasks handling, training, and objectives according to the organizational goals.
Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects and support other QA dept activities- second approval of batch release and graphics, CAPA/Corrections, quality agreements.
Lead Quality Management System compliance (EN ISO/ISO 13485 and MDSAP) and Quality System activities related to regulatory requirements (such as MDR 2017/745, MDSAP, etc.).
Lead QA Specialists/Engineers who are responsible for customer complaints handling- investigation, root cause analysis, Risk Based Approach, applicable corrections/corrective actions, Returned Material Authorization (RMA) and Returned Goods Authorization (RGA) handling.
Lead QA Specialists/Engineers who are- responsible for the sites complaints trending, support RA in identifying Adverse Events/Hazardous situations and provide inputs into the applicable product and process risk management (dFMEA/pFMEA).
Lead QA Specialists/Engineers who are- responsible for the sites supplier quality management, audits, Quality agreements, SCARs, point of contact to customer/third party related matters/ inquiries/ questionnaires, Perform supplier/subcontractor and internal audits.
Lead the sites external audit program- verifying the readiness of all applicable personnel and processes, execute CDAs with the auditing party, perform preparations meetings with functional managers/team leaders/personnel. Execute External audits by any third party, customer, applicable regulatory authorities, and Notified Body, while working within a multi-functional team environment for medical devices. Perform routine follow ups on External audits status, issue Corrections/Corrective actions and communicate responses to third party, customer, applicable regulatory authorities, and Notified Body.
Lead the sites quality system procedures maintenance by verifying their compliance to relevant regulatory requirements, and their alignment with applicable west Enterprise procedures.
Leading the site preparations of periodical management reviews.
Lead the risk management policy file maintenance activities.
Requirements: B.Sc. - Chemistry/ Biology/ Eng. an advantage
Minimum 8 years working in quality systems in the Medical Device industry
Relevant work history and/or experience may be considered in lieu of degree
Experience with customer interface and meeting customer expectations
Experience Risk Based Approach, Root Cause Analysis, Customer complaints, CAPA, Internal Audit
Experience with writing and reviewing Quality agreements- Advantage
Proven experience with ISO 13485, MDSAP and CE audits- Advantage
Excellent written and oral communication skills
Excellent critical reading and writing skills
Must have effective problem solving and interpersonal skills
Ability to work independently, multi-task and thrive in fast-paced environment
Problem solving including root cause failure analysis methods
Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to comply with the companys safety policy at all times
This position is open to all candidates.
