Quality Engineer

Job Title: Quality Engineer I

Location: Arden Hills, MN 55112

Duration: 06 Months Contract (Possible Extension);

Job Description:

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, 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.
• Role will be a part of the Post Market organization focused on product complaint investigations and approvals.

Key Responsibilities

• Ensure quality, compliance, and consistency of product investigations via product investigation review and approval.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective 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 execution of streamlined business systems which effectively identify and resolve quality issues.
• Will lead monitoring and tracking of investigation WIP and coordination with external entities to ensure on time compliance.

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Part of the Clients Arden Hills (St Paul) Post Market Complaint Investigation team performing tactical level execution of complaint investigation review & approval of over 50 medical device products of varying nature.
• Will need to develop a baseline understanding of our product line and in-depth knowledge of our Post Market investigation work instructions and requirements.
• Will collaborate with a team of over 15 people in three different countries to refine and execute the approval process.
• With bandwidth and appropriate experience, may be assigned other potential project work based on experience and interest to support continuous improvement projects or track/monitor external vendor investigations.

Qualifications

0 - 1 Year with BS

Additional Job-Specific Requirements:

• Knowledge of medical products and especially medical capital equipment systems a plus.
• Technical or Medical degree program preferred.