Product Quality Engineer

Hologic ,
Manchester, Greater Manchester
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Job Description

Product Quality Engineer **Post Date** **1 day ago** Hologic is the market leader in the women's health industry with three different divisions, all offering unparalleled diagnostic and treatment solutions. In the regulated markets where businesses are awarded on a tender basis, our capability to win the deal comes from seamless combination of Customer solution definition (Commercial and Technical content) together with flawless execution of all tender requirements (Administrative content and process). **ROLE PURPOSE** 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 root cause analysis, statistical techniques and risk management to ensure the continuing suitability, adequacy and effectiveness of Hologic's 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. + 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, test plans, 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 + 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;, QCS requirement specifications, SOPs, work instructions and forms, investigations,CAPAs, and any pertinent test data. 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) + 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** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **EDUCATION AND EXPERIENCE** 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, Method Validation, Change Control, and Design Control processes + Proficient in concepts of statistics, sampling plans and statistical analysis + 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 + Solid oral and written communication skills + Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation + Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively **PHYSICAL DEMANDS** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform

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