**Job Title**: Quality Engineer Junior Temporary
**Department**: Quality Assurance
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**Main Purpose of Job**: (Brief Summary)
- Provide Quality Engineering support to the development and production of Class I and II Medical Devices. Represent Quality in production process efforts, quality planning, FMEA and Risk Analysis, support new product development activities. Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology. Participate in or lead Corrective/Preventive Action initiatives. Support internal/ external audit, vendor qualification and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.
- Assure site activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines, and facility SOPs and Policies and customer requirements. Support organizational Quality/ Business Goals and Objectives. Responsible for the ongoing development, monitoring and evaluation of Vention's Quality programs and systems, including testing to standards and specifications.
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Main Job Duties/Responsibilities (List most important first)
- Follow and assure that personnel comply with FDA Quality Systems Regulation, ISO Standards and SOP's as defined by Vention's policies, practices and procedures.
- Insure that all record keeping and documentation is completed in a timely manner according to established policies, practices and procedures.
- Develop and recommend plans, programs and policies required to meet established objectives and, upon approval, obtain objectives.
- Participate in IQ/OQ/PQ activities including the drafting or review of protocols and reports. Qualify/ Validate production processes.
- Continuously review methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies. Make recommendations and, upon approval, implement. Motivate subordinates to recommend improvements.
- Independently perform machine and process capability and performance studies; recommend and, upon approval, lead and implement changes and upgrades to systems, procedures and processes to improve product quality.
- Independently lead problem solving efforts to identify and resolve sporadic and chronic quality issues to insure production of safe and effective medical devices.
- Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to insure that safe and effective products are produced. Provide written reports and supporting documentation of compliance and for recommendations.
- Assist in and provide Quality Assurance variance reports; review variance reports developed by staff; provide feedback to management on results, provide solutions and recommendations when applicable; recommend studies and analysis to solve variance and quality problems.
- Train Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product audits, procedures, environmental controls, etc. Request training or training support through the Training function.
- Manage and motivate staff to obtain company goals, including defining and communicating expectations and assignments, monitoring results, coaching, motivating and following up to achieve goals.
- Monitor employees, facility, equipment and processes related to safety. Recommend improvements and, upon approval, implement.
- Lead or participate in internal/external Quality System audits.
- Independently lead or participate in customer complaint investigations, document findings and provide reports and analysis; insure that documentation and findings are completed in a timely manner and in compliance with FDA standards and procedures and recommend actions or changes to improve quality.
- Assist in the development and assessment of Vention's Vendor Program; address problems and recommend solutions to vendor quality; interface as necessary to insure product specifications are met.
- Review changes to products in production for reliability impact to aid in the correction process, design or material problems.
- Independently inspect components and finished goods for compliance to specifications.
- Maintain effective working relations, communications and feedback with all other departments.
- Maintain required personal level of business and technical expertise. Participate in industry, professional and community meetings, seminars, etc.
- Perform other duties as required
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Knowledge / Education
- Senior student in Engineering or related field.
- Knowledge on ISO 13485 AND Knowledge on CRF 820 CGMPs is a plus
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Job Experience
- From 0 to 1 year work experien