Quality Engineer

Launch Your Career Today with Advantage Technical!

Are you ready to make a direct impact on the development of groundbreaking medical technologies? Advantage Technical is hiring a Quality Engineer in the Minneapolis, MN. This is your opportunity to develop your career and contribute to world-class healthcare solutions!

Hours & Pay

Pay Rate: $55 per hour

Schedule: 8:00 AM - 4:30 PM

Qualifications

• A bachelor's degree in Mechanical Engineering, Biomedical Engineering, or Electrical Engineering
• 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment and self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment

Preferred Qualifications:

• Previous Software or Capital equipment Design Assurance experience is a plus
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304)
• Experience with 60601, software, and cybersecurity
• Experience working in an Agile environment

Quality Engineer Key Responsibilities

• Support the execution and documentation of Design Validation & Verification and Usability activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
• Update and maintain product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Evaluate and support design, test, and inspection method development, and lead method validation activities.
• Support regulatory submissions to notified bodies.
• Understanding of technologies incorporated into design.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

Ready to elevate quality and innovation?

This is more than a job-it's a stepping stone to building a career with purpose. Click Apply Now to be considered for this opportunity!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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