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Quality Engineer

Job Category:  Quality
Work Location:  Corbion Site
Office Location: 

Tucker, GA, US

Job Type:  Full Time
Job ID:  1901

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 and pharmaceutical industry. Our products are used, among other things, in the production of surgical aids and slow-release medicines (injection pills). The products are developed and produced (often to customer specifications) in our factories in The Netherlands and the United States. This requires very intensive contact with the customer.

 

The application area and the specific market require a very high level of Quality and service. The Corbion Biomaterials Quality Assurance department ensures that raw materials, production processes, packaging, storage, transport and service continuously meet and exceed these high standards. This makes sure that our customers receive the consistent high Quality product from Corbion that they have become accustomed to.

 

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 the production of polymer excipients used in drugs and medical device raw materials. In this role, you will be responsible for creating Quality Management System (QMS) procedures for commercial products that are in compliance with applicable GMP standards and regulations, including ISO 9001:2015. You will also serve as a core member of the Melt team to ensure that products are developed and produced per the QMS procedures.

 

Responsibilities:

  • Support and continuously improve the QMS in compliance with GMP regulations and ISO 9001:2015 requirements.
  • Quality Reviewer for Validation and Production Documentation.
  • Support Commissioning activities for new equipment.
  • Provide direct Quality support to Production, including CAPA, Deviations, Change Control, Investigations, and line clearance.
  • Develop appropriate statistical measurements and statistical process control.
  • Support risk management activities, such as FMEA.
  • Support development of proper controls and sampling for manufacturing activities.
  • Perform data trending.
  • Maintain current knowledge of applicable GMP regulations, guidance’s, and standards.
  • Support internal and external customer Quality requests with timely follow up and participation in new business development projects.

 

Minimum Qualifications:

As a successful candidate you are a seasoned professional with experience in pharmaceutical, medical device, or related FDA regulated industry and a working knowledge of GMP Regulations and Guidances.

In addition we expect the following qualifications:
 

  • Bachelor’s or Master's degree preferably in Engineering, Life Sciences, or other relevant disciplines.
  • Minimum 5 years of Quality Assurance experience in pharmaceutical, medical device or other related industries.
  • Strong written and verbal communication skills.
  • Exposure to regulatory agency inspections and/or notified body audits.
  • Proven ability to work cross-functionally to achieve business outcomes.
  • Attention to detail, commitment to Quality, accuracy, efficiency, and consistency.
  • Experience executing validation protocols.
  • Experience leading and/or executing risk assessment activities, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
  • Proven skills in statistical methods, statistical process control, sampling plans, and design of experiments.
  • Proficiency using Microsoft Office Suite.
  • Self-motivated, and possess strong organizational, 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.
  • Must be excited to develop new products and processes.
  • Preferable ASQ certification – Certified Quality Engineer (CQE).

 

Our offer

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.

 

 

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 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

 

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.


Nearest Major Market: Atlanta

Job Segment: Quality Engineer, Medical, Engineer, Manufacturing Engineer, Engineering, Quality, Healthcare

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