At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.
Our Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical device and pharmaceutical industry. Our products are used, among other things, in the production of surgical aids and controlled release medicines. These products are often developed and produced to customer specifications. This requires very intensive contact with the customer and a very high level of quality and service.
As our next Quality Engineer, you will be responsible for ensuring procedures, systems, and processes effectively meet the Quality requirements and business needs for the site in Tucker, GA USA. The ideal candidate must have proven skills in developing and maintaining quality systems for medical devices and/or medical device raw materials. In this role, you will create Quality Management System (QMS) procedures for commercial products, as well as support the North American R&D team, that are in compliance with applicable GMPs and Quality Standards, i.e., ISO 13485:2016 and ISO 9001:2015.. You will also serve as a core member of the FiberLive development team and future R&D product teams to ensure that complex medical devices and biomaterial products are designed and developed in compliance with GMPs and the QMS. The position level may be adjusted corresponding to your experience and qualifications.
Maintain and continuously improve the Quality Management System in compliance with GMP regulations and ISO 13485:2016 and ISO 9001:2015 requirements.
Lead the site ISO 13485:2016 certification project.
Lead Risk Management program.
Provide direct quality support for CAPA/Deviations/Change Control, DFMEA, PFMEA and residual risk analysis, etc.
Assist in the development of appropriate statistical measurements.
Support customer audits, certification audits, and complaint handling.
Support internal and external customer quality requests with timely follow up and participation in new business development projects.
Review product life-cycle documents and deliverables, e.g., reports, SOPs, studies, protocols, batch records, etc.
Provide compliance and quality guidance for process and cleaning validation.
Drive establishment of proper controls and sampling for development and manufacturing activities.
Perform data trending.
Lead medical device Change Control activities.
Provide compliance and quality guidance for design verification, design validation, shelf life stability studies, simulated distribution studies, feasibility studies, and test method validations.
Lead medical device supplier quality activities.
Other duties as determined by business needs.
As a successful candidate, you are a seasoned professional with experience in pharma, medical device, or related FDA regulated industry. You have working knowledge of GMP regulations, primarily ISO 13485 and ISO 14971; and/or other applicable GMP regulations. In addition we expect the following qualifications:
Bachelor’s or Master's degree in Life Sciences, Engineering, or other relevant discipline.
Minimum 10 years of Quality Assurance experience in pharmaceutical, medical device or other related industries.
Exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.).
Proven ability to work cross-functionally to achieve business outcomes.
Attention to detail, commitment to quality, accuracy, efficiency, and consistency.
Significant experience to independently develop and execute validation protocols, test methods, and standards for the Design, Verification, and Validation of medical device products.
Experience leading and/or executing risk assessment activities, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
Skills in statistical methods, statistical process control, sampling plans, and design of experiments.
Proficiency using the Microsoft Office Suite.
Self-motivated, and possess exceptional organizational skills, and outstanding written and verbal communication skills.
A positive, team-player attitude is a must.
Must be able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced environment.
Requires high accuracy, thoroughness, and attention to detail in reviewing and completing quality records.
We offer competitive remuneration and benefits. What makes Corbion special is the way we consciously create that connection between the product of our work and our individual lives and use it to shape our choices and our priorities as a company. We have a great company made up of talented, dedicated people – people who share a purpose and a vision. When we all understand how we intend to get there in the same way, there’s no telling how far we can go. We offer you the chance to join a company with a:
Culture to empower people and where your initiatives and ideas make a real difference
International focus with truly diverse teams
Unique possibility to be trained by our internal expertise in the world of biobased products
We invest in relevant training courses related to your particular discipline, that will give you the opportunity to grow into an industry expert
Lastly, we offer a friendly, informal culture in a demanding professional environment
In addition, we actively embrace diversity in how we work together and contribute toward our shared objectives and values. By joining Corbion, you will become an employee in a company where you can feel pride in your achievements and develop your career with global prospects.
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 2020, Corbion generated annual sales of € 986.5 million and has a workforce of over 2250 employees. 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
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.
Internal Number: #1756
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 2020, Corbion generated annual sales of € 986.5 million and has a workforce of over 2,250 employees. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com