Temporary Product Quality Engineer (12 month contract) £30,000+bonus- Wythenshawe Our client is the market leader in women health industry with three different divisions,...
Temporary Product Quality Engineer (12 month contract) - £30,000+bonus- Wythenshawe
Our client is the market leader in women health industry with three different divisions, all offering unparalleled diagnostic and treatment solutions.
Ensures that all processes that support the Quality department including the handling of complaints, product transfers, NCRs, Quality System Investigations (QSI) and CAPAs. This will be applied through the application of design control, method validation, root cause analysis, statistical techniques and risk management to ensure the continuing suitability, adequacy and effectiveness of the Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Supports Product Quality Engineering through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness, through MRB, PQC
- Ensures current and applicable good manufacturing practices (GMP) and good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / IVDR) to team and Manufacturing Operations staff
- Creates documentation associated with product quality engineering activities including quality plans, test plans, protocols and reports and the update of quality system and department procedures
- Defines technical investigations plans, reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements
- Attends regular communication meetings with cross-functional teams to identify the root cause of problem and create remedial plans for short-term and long-term resolutions
- Supports change control activities and document management requirements by collaborating with applicable departments and peers to requirements for individual project
- Supports the transfer activities ensuring compliance with procedures and current regulatory requirements to ensure manufacturing capability / reliability
- Applies risk management and facilitates risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA) associated with projects
- Ensures writing/revision or reviews and approvals required on a variety of lifecycle documents. Document types include but are not limited to; cleaning validations, QCS requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations (where required), CAPAs, any pertinent test data, and validation reports
- Performs investigations and troubleshoots problems for continual improvement
- Supports activities associated with aspects of the Quality Management System including; Status of Non-Conformances and CAPAs, Participation in Material Review Board (MRB) and Participation in compliance meetings
- Ensures lab and working areas are in compliance with GMP, QSR & ISO requirements
- Maintains QC material inventories, were required and ensures inventory management through ERP (Oracle) transactions
- Performs diagnostic assay and/or amplified assay consistently with acceptable results, were required
- Performs basic troubleshooting to resolve unexpected results when performing Diagnostic and /or amplified assays
- Perform other related duties as assigned
Qualifications and Experience:
- BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through 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, Method Validation, Change Control, and Design Control processes
- Proficient in concepts of statistics, sampling plans and statistical analysis
- Good grasp of technology supporting molecular biology
- problem solving (NCR) in a regulated environment
- Technical/labs skills
- Diagnostic Experience
If you feel you have the right skills and experience for this role please apply online or call 0161 868 2200
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.