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You will be updated with latest job alerts via emailGENERAL SUMMARY OF POSITION
Lead the QA Department and manage all QA functions at the Plant (manufacturing site) working with cross-departmental leadership to deliver high quality and compliant products on schedule.
Establish and maintain a QMS to ensure that the companys facilities equipment personnel methods processes procedures and products comply with applicable corporate guidelines applicable local national and international regulatory standards and GMP.
Provide leadership and direction for the organizations QMS and processes and define and promote a quality mindset across the entire company.
Assist in the definition of Company goals and objectives and subsequently to assist in control QA budgets to ensure achievement of Company financial plans whilst meeting customer and regulatory/legislative requirements
KEY POSITION REQUIREMENTS
Education
Degree in Science Engineering or equivalent.
Job Experience
Minimum 5 years of experience in managing Quality Department (Medical Device industry for healthcare).
Experience in managing FDA inspection (for Medical Device manufacturing Plants only).
Experience in problem solving and product quality improvement.
Be able to work independently structured and systematic.
Experience in Statistical Techniques process Improvement Tools used in manufacturing process e.g. SPC Six-Sigma (Green Belt).
Knowledge and Skills
Hands-on experience with Quality System Standards
Good knowledge inISO 9001 ISO 13485 (for medial only) 21 CFR REACH GMP and QMS requirement
Auditor qualification
Process control effective manufacturing/QA control
Good analytical skills and attention to details.
Good drive for results and commercial access.
Desirable Job Competencies
Leadership
Embraces new technologies shares knowledge achieves department goals/KPIs motivates teams maintains strong connections within Ansell provides training and demonstrates urgency and commitment to project timelines.
Teamwork
Team player who builds strong relationships with suppliers internal customers and cross-functional departments.
Communication
Good written and verbal communication skills in English with the ability to engage effectively across all levels and geographies and provide and receive constructive feedback.
Interpersonal
Good interpersonal and organizational skills; self-motivated and independent.
Proven global team player effective with team members internal partners and suppliers.
Proactive and results-oriented focusing on quality cost savings flexibility and risk management.
Delivers accurate effective and consistent high-quality work.
Innovative in process improvement and problem-solving.
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.
Required Experience:
Manager
Full-Time