Manufacturing Quality Engineer
Our client is seeking to recruit Manufacturing/Regulatory Quality Engineer to ensure the Manufacturing Processes, Products, and Systems are in compliance with the requirements set out in Validations, Customer Specifications, Quality & Manufacturing Specifications, Control Plans, and relevant International Standards as applicable.
The role will involve collaborating cross-functionally with various departments within the business unit. The role will also involve assisting the Quality Department with investigations into Non-Conforming Events and Complaints, by providing Root Cause Analysis and CAPA identification & implementation.
The role will also involve the update/maintenance of product regulatory requirements. This position shall also involve training of Technicians, TPAOs, and PAOs to ensure manufacturing personnel are compliant with the requirements of the Quality System
Principal Duties and responsibilities:
Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence.
Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging.
Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives.
Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures
Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality
Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements.
Support the Manufacturing Engineer and cross functional teams on the collation of data and the resolution of processing issues.
Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department
Lead Manufacturing Driven initiatives with respect to quality within the department
Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release.
Maintain effective open communication within the team and foster cross- functional relationships
Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required
Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
Maintain work areas, equipment and supplies in a manner which conforms to the requirements of the business quality system, 5S, GMP and safety.
The ideal Candidate should Possess the following criteria:
The Manufacturing/Regulatory Quality Engineer will have a primary degree or equivalent in Engineering/Science discipline.
Medical device manufacturing experience is essential, 4 plus years.
Hands on experience in Medical device manufacturing are essential.
Must have a good working knowledge of production and quality system requirements in the health care industry
A Green or Black Belt in Lean Six Sigma would be a distinct advantage
Have the ability to effectively manage a simultaneous range of diverse activities.
Be a self-starter with good motivational and inter-personal skills.
A Practical level-headed individual with strong technical ability.
Have an ability to work hands-on engaging with cross-functional groups , equipment and materials vendors to resolve technical issues.
A structured approach to problem solving based on the utilisation of data.
If you would like to apply for this position you can contact Aileen @ Arcon Recruitment on 0949029944 or Email CV to firstname.lastname@example.org