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13 days ago
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Quality Assurance Engineer


Simply Recruitment Partner
Salary band: $10k - $15k
Location: North America, United States, Ohio, Cleveland
Job type: Permanent
Contact: Scientific Search
Category: Quality Engineer
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Job Description:

OBJECTIVE The Quality Engineer will ensure that the Quality Management System and quality standards of the company are implemented and maintained in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The Quality Engineer will serve as a delegate to the Quality Manager. SCOPE OF POSITION The main responsibility of the Quality Engineer is to ensure adherence and a commitment to corporate and/or local policies, rules, and regulations through the establishment and maintenance of an effective Quality Management System. An employee in this position must focus on customers' expectations (both internal and external) and strive for continuous improvement. Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including: - Document control and review/approval of controlled documents - Change management and review of change controls - Investigation and CAPA management, including robust root cause analysis - Complaint management and performance of complaint investigations - Supplier quality management and performance of supplier audits as appropriate - Internal audit program and performance of internal audits - Training program; conduct training when needed - Implementation of Quality Risk Management in relevant aspects of the QMS - Management Review - ISO certification and maintenance Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. Customer support, including: - Support customer audits, including response and corrective action tracking - Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication. BACKGROUND/SKILLS Bachelor's Degree - Life Sciences or Engineering. Minimum five (5) years of experience in a regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharma, or medical device). Minimum three (3) years in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment. In lieu of a Life Sciences or Engineering degree, a Bachelor's Degree and 10 years of experience in a regulated industry and seven (7) years in a Quality role will be considered. Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. ASQ certifications desirable (e.g. CQE, CQM, CQA) Demonstrated understanding of Lean Manufacturing concepts desirable Excellent analytical / problem solving, project management, interpersonal and organizational skills required. Must have excellent verbal and written communications skills to interact with internal and external personnel on plant processes, projects, and investigations. Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner. Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project Client offers a competitive salary package that is dependent on qualifications and experience as well as good benefits package plus participation in a companywide bonus plan. Interested candidates should submit current resume along with salary history. For a faster response please include job code in subject line. Please note that all candidates applying must have proper US work authorization, client will NOT sponsor.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.
Job Description:

OBJECTIVE The Quality Engineer will ensure that the Quality Management System and quality standards of the company are implemented and maintained in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The Quality Engineer will serve as a delegate to the Quality Manager. SCOPE OF POSITION The main responsibility of the Quality Engineer is to ensure adherence and a commitment to corporate and/or local policies, rules, and regulations through the establishment and maintenance of an effective Quality Management System. An employee in this position must focus on customers' expectations (both internal and external) and strive for continuous improvement. Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including: - Document control and review/approval of controlled documents - Change management and review of change controls - Investigation and CAPA management, including robust root cause analysis - Complaint management and performance of complaint investigations - Supplier quality management and performance of supplier audits as appropriate - Internal audit program and performance of internal audits - Training program; conduct training when needed - Implementation of Quality Risk Management in relevant aspects of the QMS - Management Review - ISO certification and maintenance Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. Customer support, including: - Support customer audits, including response and corrective action tracking - Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication. BACKGROUND/SKILLS Bachelor's Degree - Life Sciences or Engineering. Minimum five (5) years of experience in a regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharma, or medical device). Minimum three (3) years in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment. In lieu of a Life Sciences or Engineering degree, a Bachelor's Degree and 10 years of experience in a regulated industry and seven (7) years in a Quality role will be considered. Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. ASQ certifications desirable (e.g. CQE, CQM, CQA) Demonstrated understanding of Lean Manufacturing concepts desirable Excellent analytical / problem solving, project management, interpersonal and organizational skills required. Must have excellent verbal and written communications skills to interact with internal and external personnel on plant processes, projects, and investigations. Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner. Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project Client offers a competitive salary package that is dependent on qualifications and experience as well as good benefits package plus participation in a companywide bonus plan. Interested candidates should submit current resume along with salary history. For a faster response please include job code in subject line. Please note that all candidates applying must have proper US work authorization, client will NOT sponsor.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.

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