Senior Quality Engineer - Minneapolis

Responsibilities

• Develops, modifies, applies, and maintains rigorous quality standards and protocols for processing materials into finished products, with a specific focus on the sustaining and post-market phases of the product lifecycle.
• Collaborates with engineering, design, and manufacturing functions to ensure quality standards are established and maintained, including providing Design Quality oversight for product changes, design change analysis, and Design History File (DHF) maintenance.
• Demonstrates strong expertise in risk management by devising and implementing methods and procedures for inspecting, testing, and evaluating product precision and accuracy, and supporting complex risk assessments (e.g., product risk and field action support).
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Safeguards corrective measures to meet acceptable reliability standards and ensures documentation is compliant with all regulatory requirements.
• Maintains travel to design and manufacturing sites within the USA to support technical projects, audits, and design quality reviews.
• May specialize in design quality, product evaluation, reliability engineering, and process quality as they apply to the management of released product portfolios.

Requirements

• Requires a Baccalaureate degree
• Minimum of 4 years of relevant experience OR an advanced degree with a minimum of 2 years of relevant experience
• Nice to have: Site transfer experience, Pharma or combination product Risk Management

Qualifications

• Physical Job Requirements: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Skills

• Strong expertise in risk management
• Advanced inspection, testing, and statistical analysis methods
• Design Quality oversight for product changes
• Collaboration with engineering, design, and manufacturing functions
• Travel to design and manufacturing sites within the USA

Benefits

• Competitive Salary
• Flexible Benefits Package
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)