Quality Engineer

Fantastic opportunity to join a global manufacturer of innovative market leading medical devices, an organisation that have been at the forefront of the coronavirus pandemic and continue to grow their teams at a rapid rate.

Responsible for the continual improvement of processes and records related to validation, to drive improvements within the organisation and within the implementation of relevant and timely actions [including corrective and preventive], to ensure the continuing suitability, adequacy, and effectiveness of the company’s Quality System.

• Mentors and advises the organization on what is required in validation master plans, and related protocols and reports.
• Develops, reviews, and approves master validation plans, strategies, protocols, and reports.
• Establishes and evaluates adequacy of validation methods for new or modified processes, equipment, or facility changes.
• Reviews and approves validation protocols and reports in conjunction with the supporting data and documentation for adequacy and completeness.
• Evaluates adequacy of specifications for new or modified designs.
• Develops quality systems, performs gap analysis, makes recommendations and initiates plans to improve existing systems.

• BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 6 years’ experience in the in vitro diagnostics, medical device, or pharmaceutical industries.
• Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements.
• Must have advanced knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes
• Proficient in a variety of validations and data evaluation methods
• Proficient in spreadsheets and word processor applications
• Proficient in concepts of statistics, sampling plans and statistical analysis
• Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations
• Proficient in a variety of validation methods & evaluation criteria
• Proficient in statistical principals of DOE, ANOVA, SPC, C_pk etc.
• Proficient in understanding of engineering drawings and symbols.
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Must demonstrate initiative, balanced assertiveness working as a team player.
• Solid oral and written communication skills
• Ability to manage multiple projects.