Job Description

Akkodis is seeking a Quality Engineer for a Contract job with a client in Maple Grove MN. Ideally looking for applicants with a solid background in the Medical Device Manufacturing industry.

Pay Range: $40 - $45/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Please find the attached JD Below

JOB RESPONSIBILITIES INCLUDE:

• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Perform regulatory standard assessments and support regulatory submissions to notified bodies
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)

Minimum qualifications:

• Bachelor’s degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
• Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
• Demonstrated use of Quality tools/methodologies
• Strong verbal and written communication skills
• Self-motivated with a passion for solving problems and a bias for action
• Effectively work and collaborate in a hybrid (onsite plus remote) environment

Preferred qualifications:

• Prior medical device industry experience, particularly with medical electrical equipment
• Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
• Experience in managing multiple projects across multiple organizational disciplines

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pays upon meeting eligibility criteria.

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