• Job Description

  Req#: 107093
  !*!
  Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.
  
  Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or during their leisure time, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.
  Associate Manager - Quality Assurance
  GENERAL SUMMARY
  This position requires clear understanding of all regulatory and quality standard requirement as appropriate. Eg: ISO 9001, ISO 13485, EN ISO 13485, FDA QSR, JPAL, AS/NZS, MDR, Brazil GMP, PPER. Overall handling of customer complaints compliance to ISO 9001, ISO 13485, EN ISO 13485, FDA QSR, JPAL, AS/NZS standards etc. relevant to Healthcare Global Business Unit. Coordinating packaging artwork implementation with Marketing team/PPM and preparation of Standard Operating Procedures relevant to packaging materials
  JOB ROLE
  • Product registration in Local regulatory authorities for Local & Foreign market
  • Coordinate product registration activity between the plant and regional RA team got foreign product registration.
  • Manage & coordination external audits (Customer, regulatory & notified body).
  • Coordinate Internal quality audit
  • Coordinate Corporate Quality Audit (CQA).
  • Coordinate Management review & publish MR Meeting Minutes.
  • Training need analysis
  • Review document against the requirement for Technical File & Medical Device File
  • Submission Technical File & Medical device File documents to reginal RA
  • Coordinate, review & update packing specification packaging artwork & labeling in Ansell Web Center.
  • Master Data Management related to QA Function in Dynamic 365.
  • Initiate continual improvement project triggered on the complaint data analysis and internal data analysis.
  • Monitor and track the customer complaints from receiving to response including registering, coordinating with relevant departments to conduct the investigations, report preparation, updating TrackWise system, etc.
  • Maintain the response time of customer complaints at the given target.
  • Prepare regional and internal customer complaint reports as required to review at the given intervals
  • Follow up on customer complaint actions completion and make sure the changes are validated as appropriately.
  • Responsible for maintenance of all office equipment under QA record office.
  • Responsible for document control, record control.
  • Coordinate with relevant parties (marketing, sourcing, design etc.) and get the right information to update SOPs
  • Coordinate with packing section to get prepare samples and get them approved from relevant authorities and implement the SOPs.
  • Conduct Internal Quality Audits.
  • Safety of the employee and good housekeeping and orderliness in QA area
  • Maintain standard and regulatory document.
  KEY POSITION REQUIREMENTS
  Education
  • Bachelors of Science or relevant Degree
  • Master of Business Administration would be an added qualification
  • Lead auditor ISO9001, ISO13485
  • Diploma in Quality Management
  Job Experience
  · At least 5-7 year experience in Quality Management System & Regulatory Affairs
  Knowledge and Skills
  • High degree of computer literacy
  • Application of SPC & Minitab
  • Data analysis and report preparation
  • Internal auditing skills
  • Preparation of presentation slides
  Desirable Job Competencies: Ability of interact with internal and external customers at all levels to develop relationship. Good knowledge of the quality management systems Good interpersonal and presentation skills

  Additional Requirements (travel, etc.) Be prepared to travel to local establishments and other Ansell locations as required by the company on business- and job-related matters.
  Equal Opportunity Statement
  “Ansell commits to securing an equal opportunity recruitment and selection process. All interested candidates are encouraged to apply and will receive consideration for employment regardless of age, sex, gender identity, sexual orientation, race, color, ethnic origin, religion, disability, genetic information, or any other factors that could be deemed discriminatory.”
  
  LK Biyagama Biyagama Export Processing Zone (3445611)
  Biyagama Export Processing Zone
  Malwana
  Biyagama
  
  

• About the company

  Ansell is an Australian company which manufactures protective industrial and medical gloves.

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