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.

Key Responsibilities:

• 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.
• Lead in the implementation of manufacturing assurances, and process controls designed to meet or exceed internal and external requirements.
• Acts 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 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 & Equipment Qualification Experience.
• Manufacturing line support experience.