Quality Engineer

Job Title

Quality Engineer - Contract located near Minneapolis, MN

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. MEC’s vision is to align clients’ needs with the best resources, proactively create roadmaps for ongoing improvement, and close gaps between current and FDA expected stages.

This position will support a significant product development project with high visibility, providing a candidate with excellent opportunity and product development experience. The role applies quality engineering directives within a design assurance or development quality team supporting process validation, equipment qualifications, manufacturing line support, risk management, product development and regulatory and standards compliance. The engineer maintains a collaborative partnership with cross‑functional team members to protect patient/user safety and meet business needs.

They develop, establish, and maintain quality engineering methodologies that meet client customer and regulatory requirements and represent quality on departmental, functional, site, divisional and corporate quality goals.

• Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of new product development products to meet or exceed internal and external requirements.
• Lead in the implementation of manufacturing assurances and process controls designed to meet or exceed internal and external requirements.
• Act as an effective leader or team member in supporting quality disciplines decisions and practices.
• Apply sound systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Assure development and execution of streamlined business systems that effectively identify and resolve quality issues.

Build quality into all aspects of the work by maintaining compliance to all quality requirements.

• 2–4 years of experience with a BS
• 0–2 years of experience with a MS
• Process validation equipment qualification experience
• Manufacturing line support experience

• Process validation
• Equipment qualification experience

• Seniority level:
  Entry level
• Employment type:
  
  Contract
• Job function:
  Quality Assurance
• Industries:
  Business Consulting and Services

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change at any time with or without notice.