Design Quality Engineer II – Medical Device (Onsite – Arbor Lakes, MN) Cont at Pharmavise Corporation

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Feb, 26

Salary

0.0

Posted On

27 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Process Validation, Equipment Qualification, Manufacturing Line Support, Risk Management, Regulatory Compliance, Problem Solving, Quality Systems, Collaboration, Communication, Product Development, Streamlined Business Systems, Patient Safety, User Safety, Quality Initiatives, Team Leadership

Industry

Business Consulting and Services

Description

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: 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 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

Responsibilities

The Design Quality Engineer II will support a significant product development project, applying quality engineering directives within a design assurance team. They will maintain collaborative partnerships with cross-functional team members to ensure patient safety and compliance with regulatory requirements.