Design Quality Engineer II – Medical Device (Onsite – Arbor Lakes, MN) Contract

Our F500 Medical Device client has an exciting opportunity for a Design Quality Engineer II.

Job Summary: 

This position will support a significant product development project with high visibility which will provide the right candidate with excellent opportunity and product development experience. This role will apply the directives of quality engineering 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. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client , customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Responsibilities :

1. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of new product development products to meet or exceed internal and external requirements.

1. Lead in the implementation of manufacturing assurances, and process controls designed to meet or exceed internal and external requirements.

1. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

1. Apply sound, systematic problem-solving methodologies in identifying , prioritizing, communicating, and resolving quality issues.

1. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

• 2 - 4 Years with BS 0 - 2 Years with MS

• Process Validation & Equipm ent Qualification Experience

• Manufacturing line support experience

Additional Job Specific Requirements:

• Process Validation & Equipment Qualification Experience

Other Details:

• Schedule: 08:00:AM - 04:30:PM

• Contract Length: 6 months

• Work Set-Up: Onsite in Arbor Lakes, MN