Quality Engineer

4 weeks ago

Tucker, United States Corbion Full time

At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. In the medical and pharmaceutical market, Corbion is the market leader in the production of resorbable polymers and high-strength, degradable biocomposites for the medical device and pharmaceutical industry. Our resorbable polymers and biocomposites are used to produce orthopedic implants, drug delivery systems, and wound closure applications. We are now hiring a Quality Engineer for our facility in Tucker, GA. As our next Quality Engineer, you will be responsible for maintaining the quality management system and for providing oversight to validation/qualification and operation of processes, facilities, equipment, and computer systems in order to comply with cGMP and Corbion requirements. You will also be responsible for supporting Quality Assurance by creating, reviewing and approving protocols, procedures, reports, and other GMP records necessary to provide quality oversight and support.
Essential Job Functions :
Provide Quality oversight for commissioning, qualification, and validation of equipment, processes, utilities, facilities, cleaning, and computerized systems to ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of US FDA, industry and applicable international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support is provided to site functions.
Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
Provide support for implementing and overseeing the QMS related to the overall GMP compliance of the facility.
Assist in managing quality systems and processes, including change control (process owner), CAPA, deviations, investigations, laboratory controls, Quality Reports, and Management Review.
Contribute to quality risk analysis.
Support internal/external audits, certification audits, and regulatory inspections.
Promote a quality mindset and quality excellence approach to all activities.
Promote a safety mindset and focus on safety for all operations activities.
Reference all employee safety responsibilities in the EHS Roles and Responsibilities document.
Minimum Qualifications :
Bachelor's degree in Engineering, Chemistry, Biology, Microbiology, or a related field
5 years' experience in an FDA regulated environment
Experience drafting, reviewing, and approving validation protocols
Experience leading and/or executing risk assessment activities, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
Proficiency in data analysis and interpretation
Excellent documentation and record-keeping skills
Expert knowledge of GMP regulations and quality standards
Ability to work independently and as part of a team
Preferred Qualifications:
Advanced degree in chemistry, engineering, or other relevant area
7+ years' experience in an FDA regulated environment.
ASQ Certified Quality Engineer (CQE)
Physical Demands : The work is performed mainly in an office environment and plant operations areas where PPE is required. Through the course of a typical workday, an individual in this position will perform the following activities:
Sits
Stands
Walks
Kneels
Bends
Reaches above and below the shoulders
Must be able to wear appropriate PPE; including safety glasses, safety shoes, and clean room gowning.
About Corbion Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2023, Corbion generated annual sales of €1,443.8 million and had a workforce of 2,727 FTE. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors. Corbion provides reasonable accommodation to applicants. EOE/M/F/Vet/Disabled
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
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Medical Device, Quality Engineer, Facilities, Pharmaceutical, Medical Device Engineer, Healthcare, Engineering, Operations, Science

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