Quality Engineer

Duties include:

• Quality assurance support in the design and development support of medical device products, facilitating the application of design/change controls, risk management, quality plans, and the implementation of design and development plans.
• Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation, etc.
• Provides QA support for internal quality systems growth.
• Quality oversight of internal and external process characterization project plans, protocols, and reports.
• Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices
• Review and approve project documents to ensure adequate coverage for the project's defined scope.
• Other duties as needed.

Experience:

• BS in Engineering (or equivalent) and experience in quality assurance engineering supporting new product development is preferred.
• Excellent quality system knowledge is required.
• Working knowledge of principles, concepts, and practices for design and development activities
• MasterControl experience preferred. Functional/Technical Knowledge

Skills and Abilities Required:

• Advanced proficiency in Microsoft Office products.
• Excellent communication (written and verbal) skills.
• Excellent organizational skills
• Must be able to work independently and in a team environment.

EOE compensation is based on experience

Pay: $50,000.00 - $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Vision insurance

Work Location: In person