Design Quality Engineer III — Medical Device (Hybrid — Maple Grove, MN) Possible Temp-to-Hire

Job Description

Job Summary :

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet internal, 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.

Functional Engineering Roles include Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

• This person will be working with HM and 2 others on core team, and part of broader engineering team of approximately 10 engineers.

Key Responsibilities :

Provides leadership role on championing departmental or cross-functional engineering initiatives.

Provides project direction, coaching, and mentoring for engineering and technical team personnel.

Proactively investigates, identifies , and implements best-in-class Quality Engineering practices.

Mentor for technical guidance for identifying and resolving quality issues.

Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

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

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

Assures 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 :

4-6 Years experience with BS in Engineering. Degree must be stated on resume.

2-3 Years with MS (no restriction on MS degree)

Experience in CAPA systems

Design controls

Process controls

Must have experience in a regulated environment. Must be clear on resume.

Preferred :

Medical Device experience

Other Details :

Requirements

CAPA Systems Design Controls Process Controls