1 Validation Engineer Job in Marion, NC
Divihn Integration is Hiring a Validation Engineer Near Marion, NC
- Provide Quality Engineering support to manufacturing and product development teams for mechanical devices. Implement quality improvement projects and participate in quality activities and support a factory-focus team for a production line. Provide support for released products, evaluate field returns, and support the incoming inspection department and in-process inspections where required. Perform component qualifications and validations to support key development and continuous engineering projects.
- Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member.
- Perform return product investigations for product complaints.
- Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.
- Perform key deliverables in support of development and continuous engineering R&D projects, which include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations.
- Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans.
- Support quality control inspectors with new product inspections and quality issues that arise during inspections.
- Support and test component changes to current products.
- Support internal audits and supplier audits.
- Self-motivated worker
- Strong communication skills
- Working knowledge and understanding of mechanical drawings
- Strong problem solving, technical writing, and statistical analysis skills
- Preferred experience with supporting a manufacturing product line
- B.S. degree in Engineering
- 3-5 years in an engineering role within a Medical Device company, 2 year minimum in Quality Engineering function. Must have working experience of GMP and ISO 13485 requirements.
- Sitting/standing 8 hours per day. Light lifting may be required on occasion.
- Ability to work under a microscope
- Ability to be in a clean room environment with varying humidity levels Ability to travel occasionally.
2- Equipment Qualification
3- Automation experience
Interview: 2 Rounds
About UsDivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Job Summary
Full Time
Business Services
$72k-88k (estimate)
05/21/2024
07/02/2024
divihn.com
HOFFMAN ESTATES, IL
50 - 100
2002
Private
ROOPA RAJESH
$10M - $50M
Business Services
Related Companies
The job skills required for Validation Engineer include Consulting, Communication Skills, Problem Solving, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer positions, which can be used as a reference in future career path planning. As a Validation Engineer, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer. You can explore the career advancement for a Validation Engineer below and select your interested title to get hiring information.
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