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 correctly identify the root cause and identify robust corrective and preventive actions to avoid reoccurring problems and investigations.
* Responsible for the 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.
* Gathering, trending, and analyzing data to accurately clarify problems and identify continuous improvements across the business.
* Ensuring that investigations comply with the Quality standards implemented in the business.
* Clearly documenting investigations within the required timeframes to meet business and compliance needs.
* Participating in regulatory inspections to present and defend investigations when required.
* Ensuring the timely and effective closure of day-to-day quality issues.
* Proactively improving processes to deliver competitive advantage for both the Business and customer.
* Coaching and driving a culture of compliance and continuous improvement.
* Acting in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
* Compliance with all site Environmental, Health and Safety requirements, training, and regulations.
* Compliance with all local site company policies, procedures, and corporate policies.
* Performing 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 spreadsheets.
* 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.
#J-18808-Ljbffr