US, York, SC Quality Engineer (2022-88)
We are seeking a Quality Engineer, experienced with a fast-paced and regulated work environment, who is knowledgeable of pharmaceutical excipients and medical device manufacturing as well as ISO 13485 and FDA regulations.
The successful candidate will be motivated by a fast-paced environment where business is growing and being in 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 controlled and regulated 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 Quality 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 validation protocols, 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 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 sustaining and maintain ISO 13485 standards and considered as the subject matter expert in all aspects of the LTI quality management system. In the course of satisfying this requirement, they have responsibility for conducting investigations when there are quality issues.
- Bachelor of Science degree in engineering or a related field
- American Society of Quality (ASQ) Quality Engineer certification, ISO 13485 internal auditor certification preferred
- At least three to five years of experience working as a quality engineer in a biomedical, pharmaceutical, cosmetic, food or medical manufacturing environment. Must have working knowledge of GMP.
- Working knowledge of MS Office Suite; 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%
Elkem will conduct a post-offer background check to confirm the information provided by candidates during the recruitment process. Additionally, a post-offer physical, including a substance screening, is required. Relevant candidates will be informed of this if it applies.
We are an Equal Opportunity Employer – M/F/Veteran/Disabled and if you are an individual with a disability, who requires an accommodation, please contact us.
- Region: North America
- Division: Silicones
- Job type: Quality
- Working hours: Full Time
- Working days:
- Application deadline: 31.12.2022
- Location: York, SC