Sr. Quality Engineer

In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive support in areas of pre-production component development and production-ready component and finished device manufacturing. Actively participate in developing and maintaining the quality plans and inspection systems that ensure that all components, assemblies, or finished products meet the established quality requirements.

Responsibilities:

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Performs risk assessment activities to identify product quality or compliance risks and leads efforts to mitigate those risks.
• Assists with protocol and implements process validation procedures in accordance with QSR, FDA, and international guidelines.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Implements approved changes using sound quality engineering principles and fully documents them in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, Danvers Quality Business System, and Corporate Policies.

Job Type:

Full-time

Pay:

$55.00 - $65.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 5 years (Preferred)

Work Location:

In person