Elkem Silicones USA Corp.

Biomedical Quality Engineer

Seeking a Quality Engineer experienced with GMP/GDP, ISO 13485 and FDA regulations.

We are seeking biomedical quality engineering experience with GMP/GDP experience who is knowledgeable of pharmaceutical excipients and medical device manufacturing as well as ISO 13485 and FDA regulations to fill this newly created position.


Successful candidates will be motivated by a fast-paced environment where business is growing and a role that will have a direct and immediate impact on our operations and sales. Additionally, if you have a passion for working in a GMP/GDP environment and working to the standards of federal regulations, this may be the role for you! 

Our business is growing and is in need of an experienced Engineer who will be responsible for providing direct support to all functions in developing and maintaining Good Manufacturing Practices (GMP)/ Good Documentation Practices (GDP) and ensuring compliance with practices in support of our growing Long Term Implantable (LTI) product line. This support includes creating Process Flow Diagrams (PFD), Process Failure Mode Effects Analysis (PFMEA), Control Plans, gage validation studies, coordinating root cause investigations, and verifying critical control points in the product realization process for the Company to demonstrate that standardization and controls are in place to ensure quality products.

This role is highly technical in nature and requires a high degree of attention to detail. Having working knowledge of ISO requirements, related FDA regulations as well as our internal processes is necessary.  The successful candidate will be a point of contact with US or European regulatory bodies and will interact with various auditors.

There will be an initial focus on LTI materials and is accountable for ensuring that all related production meets documented requirements before product release. The Biomedical Quality Engineer is directly responsible for all aspects of product release activities and will work with a minimal amount of supervision.  In the course of performing this function, the Quality Engineer will audit both the manufacturing and quality team’s work.

This incumbent has the authority to formulate, affect, interpret, or implement management policies or operating practices to ensure that our products meet the requirements of our customers as well as those of related quality certification.

This position is responsible for the effective implementation of ISO 13485 and considered as the subject matter expert in all aspects of the LTI quality system.  In the course of satisfying this requirement, they have responsibility for conducting investigations when there are quality issues.

Skills & Experience
  • Bachelor of Science degree in engineering or a related field
  • American Society of Quality (ASQ) Quality Engineer certification, ISO 13485 internal auditor certification (to be verified)
  • At least 5 years of experience working as a quality engineer in a biomedical, pharmaceutical, cosmetic, food or medical manufacturing environment.  Must have working knowledge of GMP and GDP.
  • Working knowledge of MS Office package; advanced level of Excel
  • Experience with Visio, Minitab and Sharepoint preferred (or similar tools)
  • Involvement as a participant on project teams
  • Experience in a Lean/Continuous Improvement focused role.
  • Self-starter, capable of working with limited supervision.
  • Demonstrated ability to lead and influence cross-functional teams.
  • Proven record using lean manufacturing tools to drive improvement including 5S, Total Productive Maintenance, Value Stream Mapping, SMED, Toyota A3, and Root Cause Analysis (RCA)
  • Excellent written, verbal and analytical skills.
  • Good organization and time management skills.
  • Travel <10%

Engineering / Architecture

Tagged as: biomedical, Engineering, quality engineer