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 able to organize and prioritize tasks; be detail orientated and self-motivated.
- An ability to collaborate across functional teams and work effectively in a matrixed team environment.
- Must be able to work independently on own projects while working concurrently with all departments.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Must also be able to maintain confidentiality and resolve conflicts.
- Ability to make independent and sound judgments.
Competencies/Authorities
Delegation of Duties:
- When absent from the site duties and responsibilities will be delegated to the following designates
Value Stream lead- Operations