Quality Assurance manager

Job Description

Clear Sky Rcruitment are pleased to be the recruiter of choice for an established medical diagnostic business based in South Wales, On their behalf we are seeking a Quality Assurance Manager to lead there quality assurane team..OverViewMy client is a global medical diagnostics business with specialisms in point-of-care, central laboratory, enzyme manufacturing, laboratory testing and the provision of contract manufacturing services to the healthcare industry and is seeking at Quality Assurancemanager to Plan, coordinate, and direct Quality Assurance activities to ensure site Quality Management System is being managed appropriately.Essential Duties and Responsibilities

• Ensure that quality system requirements are effectively established and maintained in accordance with ISO 13485 and other regulatory requirements
• Function as the direct link between Global QA and the regional site(s) to ensure local strategies are developed and aligned in to support the global strategy
• Document Control: regulates document control system including labels, IFUs, Revision control, Operating procedures, etc. and all related documents that create the Quality Management System, meeting ISO 13485 and other regulatory requirements.
• Writes and updates standard operating procedures
• Establish and maintain product assurance standards, procedures, and controls
• Validation: monitors the execution of the Master Validation Plan
• Work directly with Human Resources to ensure local training programs are implemented which meet the Quality System requirements
• Monitors the complaint handling process
• Manages the supplier program to include the selection, evaluation, re-evaluation and approval of suppliers
• Coordinates CAPAs and non-conformance activities
• Lead CAPA/NCR/FMEA/Risk Analysis and other failure investigation activities
• Reviews and released finished goods
• Internal Audits: creates and maintains the annual internal audit program.
• Coordinates and serves as escort for audits conducted by regulatory agencies, registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers.
• Serves as Local Management Representative
• Prepare Management Review and Quarterly Review Board Meetings
• Provide reporting and improvement of all quality-related site KPIs.
• Maintain Master Device Records and Device History Records
• Interface with customers on all Quality issues
• Be responsible for investigation of formal response to all customer complaints and interface with customer quality representatives
• Support new product design and introduction

Supervisory Responsibilities

• Directly manages site QA Team.

Qualifications:

• BA/BS degree in a science related field
• 5-10 years of experience in medical device or in-vitro diagnostic industry
• Experience managing ISO 13485 Quality Management System
• Excellent verbal and written communication skills, strong interpersonal skills, and superior organizational skills
• Working experience with Lean and Six Sigma methodologies is a plus
• Certified Quality Engineer or Certified Quality Audit is a plus

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