Job Summary:Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.
Essential Duties and Responsibilities: Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
Responsible for completion of investigations in compliance with Quality standards Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business Ensures that investigations comply with the Quality standards implemented in the business Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs Participates in regulatory inspections to present and defend investigations when required.
Ensuring the timely and effective closure of day-to-day quality issues.
Proactively improve processes to deliver competitive advantage for both the Business and customer Coach and drive a culture of compliance and continuous improvement.
Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
Compliance to all local site company policies, procedures, and corporate policies.
Perform additional duties at the request of the direct supervisor Basic Qualifications: Must have a third level qualification in Engineering/Quality/Science.
Must have 3+ years' work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment Preferred Knowledge, Skills and Abilities: A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
Ideally have excellent technical writing skills.
Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3 Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
Must have excellent communication skills both oral and written.
Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
Must be able to deal with all levels of employees and work across various departments Travel Requirements: Must be able to travel up to 5% of the time or when required Physical & Mental Requirements: Must be able to work in a fast-paced environment.
Must be ab
