This is a unique opportunity to be part of a team that mainly focused on design verification and remediation per requirements based on an assessment performed by the research team. Following tasks involve ensuring design compliance, maintenance of documentation, and traceability. Performing risk assessment and generating control plan, dFEMA, pFMEA, and associated control measures to mitigate or reduce risks.
- The Validation Engineer is responsible for supporting all validation and quality engineering activities to support the product life cycle, from development of new products from concept through commercialization, through sustaining changes, as part of a cross-functional development team.
- Develop Verification/Qualification deliverables including but not limited to Work Instructions,Bill of Materials (BOM), Routers, Functional and Design Specifications, Test Protocols (IQ,OQ, PQ), Validation Deviations and Summary Reports.
- This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation.
- Responsible for all aspects (product and process) related to the quality of the designated product line(s).
- This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints and deviations.
- Develops, modifies, applies, and maintains quality standards, and generates protocols and reports.
- Responsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.
- Under close supervision, utilizes established procedures to perform routine assigned tasksand applies company policies and procedures to participate in the development, review, andimprovement of the facility's Quality Plan and manufacturing processes.
- Participates in management of product Risk Management Files.
- Continually updates information and coordinates information exchange with other FMCNA facilities.
- Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO).
- Maintains validation records and systems to keep ongoing process validations current and applicable to process.
- Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures.
- Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence.
- Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality.
- When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.
- Assists in providing in-house training (e.g., calibration, validations, batch production and operation of equipment) in conjunction with plant management to operators and other personnel, as assigned.
- Participates in product design control activities for new product lines.
- Conducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.
- Other duties as assigned
- Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving.
- Strong background in understanding engineering drawing requirements including GD&T, electrical and mechanical inspection methods, a basic understanding of special process surveys and an overall understanding of how to manage and interface with a supplier on a daily bases to support MFC Programs.
- Must have good organizational skills and be able to perform work with little supervision.
- Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills.
- Knowledge of analytical laboratory methodologies is important.
- FMCNA IMPAQ Associate.
- Excellent verbal and written communication skill.
- Strong team player with the ability to work across multiple functions and disciplines.
This is a professional position, and as such, we require, at minimum, a Bachelor's degree in a relevant engineering discipline, such as mechanical, biochemical, chemical, or electrical, or a combination of education and experience equating to the U.S. equivalent of a Bachelor's degree in one of the aforementioned subjects.
Providence, Rhode Island, US
Remote work from: US
May 9, 2022